Co-Investigators: Sara Ahola Kohut, Paula Forgeron, Adam Huber, Lori Tucker, Lori Spiegel, Ciaran Duffy, Karen Watanabe Duffy, Myla Moretti, Brian Feldman
Funding: The Arthritis Society; 2016-2019
Background: Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. When children become teens they start making more choices about their lives and their health. Being a part of making choices about your health can help teens get ready to move to an adult health-care team. But most young people do not learn how to take care of their illness on their own or get the help they need to be able to do so. Many have never met another young person also living with arthritis. That’s where a peer mentor can help. Face-to-face peer mentoring using the Internet is a new way to help teach teens with arthritis to learn how make choices about their health and get the support they need.
Objective: To find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis.
Procedure: 262 participants will be recruited from paediatric rheumatology clinics across Canada. The participants will be randomized into one of two groups: those who take part in the iPeer2Peer program and those who do not. The iPeer2Peer program matches teens with arthritis with a young adult mentor who has learned to manage their arthritis well. The teen and their mentor will talk on Skype video calls every week for 20 to 30 minutes over three months. The teens’ ability to take care of themselves, their confidence, their arthritis symptoms, their quality of life, and the extra costs of living with arthritis, will be measured before, right after and six months after the iPeer2Peer program has taken place.
Co-Investigators: Paul Nathan, Abha Gupta, Maru Barrerra, Lindsay Jibb, Sara Ahola Kohut
Funded by: Canadian Cancer Society; 2015-2017
Background: Adolescents with cancer experience many negative effects of cancer, both physical (pain, nausea) and emotional (anxiety, depression). To achieve the best possible health outcomes, these adolescents must engage in self-management and develop skills to transition to adult care. Developing these skills is complicated and, to do so, adolescents may benefit from support from older adolescents and young adults who have learned to function well with cancer. Additionally, if this peer support is provided remotely via Skype, the number of adolescents who can benefit from the support increases. In response, our group will develop and test the iPeer2Peer (iP2P) Cancer Support Program.
Objective: To develop and examine the impact of a Cancer iP2P Support Program on health related quality of life of adolescents with cancer.
Procedure: The current project will be a pilot study, involving 40 adolescents with cancer (20 will receive VP2P mentorship from a cancer survivor over 10 weeks and 20 will not receive VP2P immediately), to: (a) test the feasibility of conducting a large VP2P study, and (b) begin to examine how effective VP2P is at helping adolescents. The pilot study will help us to refine the program and inform the methodology and calculate the sample size for a definitive multi-site randomized controlled trial (RCT).
Background: Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Specifically, the insertion of a needle into an subcutaneous port (SCP) has been shown to be painful, frightening, and distressing to children, even when the skin is numbed with a topical anesthetic. A systematic review identified interventions focused on distraction and results indicated that, especially if it capitalizes on new virtual reality (VR) and Internet-based modalities, distraction is a promising means to decrease pain and distress in children with cancer.
Objective: To determine (1) whether VR interventions are safe and acceptable for children with cancer, and (2) the feasibility of VR distraction on pain intensity and distress during a painful procedure.
Procedure: In Study 1, eligible participants will be recruited from the oncology clinic (aged eight to 18 years) at SickKids. The child will be asked to play with the VR system for ~5 to 10 minutes and then participate in a semi-structured interview to determine their likes and dislikes. In Study 2, a convenience sample of 40 children and adolescents with cancer (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited and randomized. Participants in control group will watch a video on an iPad and those in the experimental group will receive the VR intervention.
Status: Currently obtaining ethics approval at study site.
Co-Principal Investigators: Vanessa Bouskill, Jennifer Stinson
Co-Investigators: Sara Ahola Kohut, Vicky Breakey
Funded by: Canadian Haemophilia Society, 2015-2016
Background: Haemophilia is a rare bleeding disorder that can be complicated to manage. While the child and family share management of haemophilia, teens are expected to take on a greater role in managing their haemophilia as they mature. Yet, most teens with haemophilia do not receive comprehensive education on how to self manage their hemophilia. Peer mentoring is proposed as one solution to address this gap in clinical care. Peer mentoring can provide meaningful social support and has also been associated with improved health outcomes. An online Skype-based peer mentoring program (Virtual Peer-to-Peer Support Mentoring Program; VP2P) exists for teens with arthritis and chronic pain. However these groups are primarily female therefore making changes to this program necessary for the male teens with haemophilia.
Objective: The goal of this study is to identify the peer mentoring wants and needs of youth with haemophilia in order to determine necessary changes to the VP2P for youth with haemophilia.
Procedure: Thirty youth diagnosed with haemophilia (n = 20 adolescents; n = 10 young adults) will be interviewed. Audio-taped interviews will be transcribed word for word and analyzed qualitatively. The data will then be used to make necessary changes to the VP2P for teens with haemophilia.
Funded by: Perioperative Services Innovation Project, The Hospital for Sick Children; 2016-2017
Background: Pain is common in hospitalized children, and often moderate to severe. Unrelieved or undertreated pain in children can negatively impact all aspects of health-related quality of life. Patient self-report is a key source of clinical information for assessing pain in children who are cognitively able to describe their pain experience and assessing pain in young children aged 4-7 years is a particular clinical challenge. Smartphones offer a highly accessible, engaging, and interactive medium to improve pain assessment and management. There are a growing number of ‘pain apps’ for patient use.
Objective: To assess Achy Penguin for: (a) ease of use, (b) ease of understanding, (c) frequency of technical and practical issues, (d) time to complete, and (e) patient satisfaction.
Procedure: Iterative cycles of semi-structured audio-recorded individual interviews will be conducted to evaluate and refine usability of Achy Penguin. Each cycle will be comprised of five to seven participants. Data will be analyzed after each cycle and the tool will be refined as needed. Testing will continue until no further usability issues are identified. It typically takes two to three testing cycles to resolve usability issues.
Status: Currently obtaining ethics approval at study site.
Co-Investigators: Fiona Campbell, Allan Gordon, Chitra Lalloo, Jill Chorney, John Clark, Saifee Rashiq, Mark Simmonds, Lindsay Jibb, Joseph Cafazzo
Funded by: Canadian Institutes of Health Research (CIHR)
Background: Chronic pain in adolescents and young adults is a prevalent problem. Improved early self-management could help to optimize disease management and reduce pain-related disability. Smartphone apps and web-based interventions provide an innovative approach to help patient’s access ‘in the moment’ coping strategies, self-monitor symptoms, set achievable goals, and develop self-management plans. While there are web-based programs for older adults and school-age youth with chronic pain, there is no comprehensive program tailored for the unique needs of adolescents and young adults.
Objective: The overall goal of this phased program of research is to develop and evaluate the first integrated smartphone and web-based pain self-management program (iCanCope with Pain) designed for adolescents and young adults with chronic pain aged 15 to 25 years.
Procedure: The researchers will develop the iCanCope app and website and then conduct testing to ensure that it is easy to use, and efficient to complete. A qualitative usability testing approach with semi-structured, audiotaped interviews and observations will be undertaken using cycles of 15 to 21 adolescents and 15 to 21 young adults to evaluate usability and refine the prototype. Afterwards, a parallel group pilot feasibility randomized controlled trial will be conducted with 120 adolescents and young adults with chronic pain. Following the 8-week study period, post-pilot qualitative interviews will be conducted with 20 to 30 participants from the intervention group to gain an in-depth understanding of their perceptions regarding the value and usefulness of iCanCope as a tailored pain self-management resource for 15 to 25 year olds with chronic pain. The pilot study will enable us to refine the prototype as well as inform the methodology and calculate the sample size for a definitive RCT across all major chronic pain centres in Canada.
Status: Recruitment will begin for the randomized controlled trial in October 2016.
Co-investigators: Ronald Laxer, Lynn Spiegel, Nadia Luca, Brian Feldman, Joseph Cafazzo
Funded by: The Arthritis Society
Background: Juvenile idiopathic arthritis (JIA) is the most frequent cause of chronic musculoskeletal pain in youth, and can negatively impact all aspects of health-related quality of life. Effective pain management requires a multi-disciplinary approach including pharmacological, physical and psychological therapies through two-way communication between the patient and health care professionals. Progress is being made to improve access to chronic disease self-management therapies through innovative approaches using smartphone technologies. However, no smartphone-based chronic pain program has been rigorously tested or specifically targets the unique developmental needs of adolescents with persistent musculoskeletal (MSK) pain due to JIA.
Objective: The aim of this phased research project is to develop and evaluate the effectiveness of “iCanCope with Pain”, the first smartphone-based pain coping application for use in adolescents with JIA.
Procedure: We will develop the iCanCope with Pain app and determine the usability of the app using semi-structured interviews conducted in two to three iterative cycles with five to seven adolescents with painful JIA per cycle to refine the prototype (total of 15 to 21 participants). The feasibility of the “iCanCope with Pain” app in terms of implementation and effectiveness outcomes from use of the app will be evaluated in a pilot randomized controlled trial study.
Status: Recruitment will begin for the randomized controlled trial in October 2016.
Co-Investigators: Brian Feldman, Ciaran Duffy, Adam Huber, Lori Tucker, Patrick McGrath, Shirley Tse, Lynn Spiegel, Julie Barsalou, Charles Victor, Mark Connelly, Sarah Campillo
Funded by: Canadian Institutes of Health Research (CIHR)
Background: Juvenile idiopathic arthritis (JIA) is a common chronic childhood illness that can negatively impact health-related quality of life (HRQL). In younger years, JIA management activities are shared by the child and family with support from health providers. Evidence supporting psycho-educational treatments in improving health outcomes in JIA is strong; yet integration of these interventions has been slow. Thus the vast majority of children and their parents do not receive comprehensive JIA education and coping skills training to promote shared disease management in order to decrease symptoms and enhance health related quality of life (HRQL). While there are Internet-based self-management programs for adolescents with JIA and adults with arthritis, to our knowledge there is no program developed to meet the needs of children and their parents.
Objective: The aim of this research is to develop and evaluate the usability and feasibility of a bilingual (English and French) interactive, Internet-based psycho-educational game.
Procedure: We will develop the bilingual psycho-educational game and conduct usability testing. A qualitative usability testing approach with semi-structured, audiotaped interviews and observation will be undertaken using iterative cycles with 15 to 21 English and 15 to 21 French-speaking participants to determine the usability of the psycho-educational game and refine the prototype. The feasibility or implementation of the psycho-educational game and the effectiveness outcomes from use of the site will be evaluated in a pilot randomized controlled trial study with 60 English and 60 French-speaking participants. Qualitative telephone interviews will be conducted with 10 to 15 English and 10 to 15 French child-parent dyads in the experimental group after they have used the game to further refine the game prototype.
Background: Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Recently, a randomized controlled trial (RCT) investigated the impact of an interactive humanoid robot capable of facilitating distraction and reducing distress during childhood immunizations. The investigators concluded that interaction with the robot significantly reduced immunization pain and distress as indicated by child-, parent-, nurse-, and researcher-reports when compared to minimal distraction. Given the demonstrated propensity for children to engage with a robot, the use of humanoid robots represents an exciting opportunity to minimize pain and distress in children with cancer and ultimately improve quality of life.
Objective: Our research objectives are to assess the feasibility of implementing the robot for effectiveness testing in a future RCT and to determine treatment effectiveness estimates, between the Medi-Port robot, programmed to distract children during an subcutaneous port (SCP) needle insertion, and an active control intervention standard medical care.
Procedure: In addition to usual care, children in the experimental condition will have Medi-Port positioned beside the patient. Medi-Port will execute a pre-programmed series of behaviours to distract the child before, during, and after the needle insertion. In the control condition, rather than executing a pre-programmed series of needle insertion-specific behaviours, Medi-Port will execute a standard set of dancing movements only. Following the procedure, children, parents, nurses, and the researcher will each rate the child’s maximum pain intensity during the procedure. In addition, children and parents in the experimental condition, as well as nurses, will each complete a questionnaire related to the acceptability of Medi-Port.
Status: Recruitment is completed and data analysis is currently ongoing.
Co-Investigators: Anne Marie Maloney, Lindsay Jibb, Paul Nathan, Annie Dupuis, Bonnie Stevens, Emily Seto, Joseph Cafazzo, Donna Johnston
Funded by: Alex’s Lemonade Stand Foundation and Canadian Institutes of Health Research (CIHR)
Background: Despite advancements in the amount and quality of pain research, adolescents with pain due to cancer and/or its treatment continue to report it as poorly managed. Achieving the best possible pain management requires collaboration between adolescents with cancer (AWC) and health-care providers to measure, deliver and evaluate pain-focused interventions. PainSquad+, a smartphone-based pain management application, represents a unique means to manage cancer-related pain in AWC in their everyday environments. PainSquad+ will leverage the gaming approach to pain assessment used in the original PainSquad app and will additionally employ a clinical care algorithm to provide AWC with real-time pain management support. The real-time support will supply AWC with immediately accessible self-management support to guide treatment decisions, preventing time delays between pain occurrence and management in this vulnerable population.
Objective: The overall goal of this project is to develop and evaluate a smartphone-based real-time pain management app for AWC. This study will contain two phases. In phase one, we will refine the PainSquad+ app using a user-centered design approach with iterative phases of usability testing. In phase two, the feasibility of trialing the PainSquad+ app and magnitude of effect estimates will be evaluated in a pre-test/post-test experimental design.
Procedure: A qualitative user-centered design approach utilizing semi-structured, audiotaped interviews and observation will be undertaken to determine the usability of the PainSquad+ interface and to further refine the prototype. We will use two to three usability testing cycles involving five to seven AWC per cycle. AWC will complete PainSquad+, recording their own pain and receiving management advice while thinking aloud about their perceptions related to the app and any difficulties encountered. Once an AWC has worked through PainSquad+, an interview will be conducted using questions on ease of use, understandability, and acceptability of PainSquad+. The feasibility of trialing the PainSquad+ app and magnitude of effect estimates will be evaluated in a pre-test/post-test feasibility study.
Status: Recruitment is completed and data analysis is currently ongoing.
Co-Principal Investigators: Jennifer Stinson, Lori B. Tucker
Funded by: Health Research Foundation
Background: Most youth with Juvenile idiopathic arthritis (JIA) will continue to experience active disease in adulthood, making the continuity of care from paediatric to adult care important. A measurement of a patient’s “readiness” to move to adult care is needed to ensure adequate preparation to thrive in the adult health care setting.
Objective: The objective of this prospective cohort study is to determine the construct validity, responsiveness, and reliability of the Readiness for Adult Care in Rheumatology (RACER) questionnaire, a tool designed to measure readiness to transition to adult care among youth with JIA.
Procedure: Participants 16 to 24 years of age will be recruited from 13 rheumatology clinics across Canada and followed for 18-months. They will be asked to complete the RACER questionnaire at five time points.
Co-Investigators: Bruce Dick, Argerie Tsimicalis, Abha Gupta, A. Lee Chong, Caroline Laverdiére, France Dupuis, Sylvie Le May, Donna Johnston, Carol Portwine & Vicky Breakey
Funded by: Canadian Institutes for Health Research (CIHR)
Background: With increasing rates of successful outcomes of paediatric cancer treatment, there has been a parallel increase in the appreciation of the acute and long-term medical and psychological sequelae of the cancers and their treatments. Adolescents have been highlighted as a unique patient group in which improvements in cancer outcomes have lagged behind both younger children and older adults, the causes of which are multifactorial. An important contributory factor to this disparity in health outcomes may be the gap between pediatric and adult health care services that leaves many adolescents and young adults vulnerable.
Objective: The overall aim of this program of research is to develop and evaluate the “Teens Taking Charge: Managing Cancer Online” Internet intervention that will help adolescents with cancer to better cope with their disease, improve their health related quality of life, and enhance readiness to transition to adult health care using a sequential phased approach
Procedure: A single-blinded, pilot RCT design will be used to test feasibility of the “Teens Taking Charge: Managing Cancer Online” intervention. 120 English and French-speaking adolescents with cancer will be assigned to the experimental or control groups using constrained randomization. In addition to standard medical care, the experimental group will receive the interactive multi-component self-guided online cancer intervention that consists of cancer specific education, self-management training, transitional skills, and social support strategies that is available in English and French. They will also receive monthly telephone contact with a trained intervention health coach, who will review the previous four weeks homework, knowledge quizzes, and goals determine module completion and answer questions regarding the material; and provide guidance on any issues that have arisen and/or direct them to their health care team.
Funded by: Kids Health Links Foundation; 2015-2016
Background: Adolescence is a developmental stage characterized by peer relationships as adolescents pull away from parents and begin to identify friends as a primary source of support. This process is disrupted in adolescents with chronic conditions as they must manage symptoms, treatments and numerous appointments. The internet has become one of the top health information resources and modes of social communication for youth and therefore is ideally suited to the provision of online services such as social support.
Objective: To improve our understanding in how to increase engagement and utilization of online resources and social support networks for youth with chronic conditions in order to promote social support, self-care disease management, coping, and overall well-being.
Procedure: 40 participants with chronic conditions will be recruited from various clinics (i.e., endocrinology, gastroenterology, rheumatology, complex pain, cardiology) at three hospitals (SickKids, Holland Bloorview Kids Rehabilitation Hospital, and IWK Health Centre). Participants will take part in a semi-structured interview, where they will be asked about their internet resource seeking habits, needs and wants in online resources/social networks, what characteristics they find helpful and keeps them engaged, as well as the types of information they seek (i.e., disease specific or general issues related to being a adolescent).
Co-Principal Investigator(s): Jennifer Stinson, Amy McPherson
Co-Investigator(s): Jill Hamilton, Catherine Birken, Michael Coons, Jordan Rivera
Funded by: SickKids Centre for Healthy and Active Kids
Background: The prevalence of childhood and adolescent obesity has increased in recent decades, posing a major public health concern as evidence indicates that obesity in childhood is associated with a range of physical and psychosocial health and psychosocial sequelae. One particularly high-risk group are adolescents with physical disabilities. Information and communication technologies have become ubiquitous among youth, creating an opportunity to develop interventions for weight management. Current weight management apps available to adolescents lack the involvement of adolescent end-users, families and healthcare professionals in their development, and have not been rigorously tested for effectiveness on weight-related health outcomes. An app that would be suitable for all adolescents- both with and without disabilities- would therefore be an innovative contribution to obesity management.
Objective: To determine the self-management needs of adolescents with obesity from the perspectives of youth, parents/caregivers and health care professionals (HCPs), in order to inform the development of a mobile and web-based application to help them to adopt and maintain healthy lifestyle behaviours necessary for weight management.
Procedure: Using a prospective descriptive qualitative design, we will conduct separate semi-structured, audio taped focus group sessions with 14 to 20 adolescents with obesity both with and without physical disabilities, their parents/caregivers, and healthcare professionals. This will determine adolescents’ self-management needs and perceptions on ideal features and functionality for a mobile and web-based healthy behavioural and lifestyle tool suitable for many different adolescents with obesity.
Status: Recruitment is complete and data analysis is currently ongoing.
*Please note that all studies below have been completed*
Co-Principal Investigators: Stinson, J and Campbell, F.
Co-Investigators: Lalloo, C and Matava, C.
Funded by: Canadian Institutes of Health Research (CIHR)
Background: Despite a plethora of paediatric pain assessment tools, acute postoperative pain in children and adolescents remains common. Currently, there is little if any support in the community to help children, adolescents and their families manage pain once discharged home after surgery. Computerized clinical decision support systems (CDSS) can be used to track symptoms over time and offer clinical guidance as well as promote doctor-patient communication and patient self-management. As such, they have great potential for improving the self-management of post-operative pain in children and adolescents following surgery. There is a growing number of smartphone applications designed to promote pain management, however, there is currently no single app designed to address the needs of children and adolescents with acute post-operative pain.
Objective: To hold a consensus conference to bring together leading experts in paediatric acute pain, system software experts and consumers to develop a consensus on the standardized self-care pain treatment algorithm(s) and clinical support tools that should be employed on the MyPOP CDSS and a plan to develop the prototype and evaluate the usability, feasibility, and effectiveness of this system on patient, provider and health services outcomes.
Procedure: A two-day consensus conference will be held in Toronto in the Summer of 2015 to establish consensus on the standardized acute pain treatment algorithm(s) for the CDSS, devise a plan of research to develop the prototype and evaluate the usability, feasibility, and effectiveness of the MyPOP CDSS and develop a plan to disseminate the findings and eventually roll out the CDSS in paediatric centres across North America. A consensus committee will be struck consisting of 21 members, chosen because of their expertise in the management of acute post-operative pain in children and or development of CDSSs smartphone applications. Afterwards, we will develop the prototype, then test the usability, feasibility, and effectiveness of the MyPOP CDSS in interested centres across North America from the perspective of the end-users.
Co-Investigators: Tsmicalis, A, Le May, S, Vachon, MF, Volpe, J, Rennick, J, Choquette, A, Yoon, S, Ruland, C, Naqvi, A.
Funded by: Pediatric Oncology Group of Ontario (POGO)
Background: Significant evidence demonstrates that children with cancer experience a large number of complex psychological, physical, school-related, and behavioral symptoms and problems during and after treatment. Sisom is an interactive, computerized tool that has shown to significantly increase the number of symptoms reported by children and improve communication in paediatric oncology clinic consultations in Norway. Children express how they feel through Sisom, which in turn can help parents and health care providers better understand and support the child. An important next step is to test the usability of Sisom with a group of children with cancer within a Canadian context.
Objective: The objective of this proposed study is to test the usability of Sisom, in terms of ease of use, usefulness, and aesthetics, from the perspective of English-speaking children with cancer.
Procedure: The testing will encompass an iterative range of processes for identifying how the children with cancer actually interact with Sisom with the goal of meeting their needs. Using a stand-alone application installed on a laptop computer for use at the point of care, the children will complete Sisom. Usability software will be used for automatic recording and analysis of all verbalizations, input device signals such as mouse clicks and movements and Sisom screen shots. Afterwards, semi-structured interviews to obtain usability-related information from the children will be conducted to assess the children’s perceptions of the Sisom application.
Co-Principal Investigators: Connelly, M, Stinson, J, Schanberg, L
Funded by: National Institutes of Health (NIH); 2011 – 2014
Background: There is a critical gap in the contemporary treatment of juvenile idiopathic arthritis (JIA) wherein a majority of adolescent patients still experience ongoing pain and reduced health-related quality of life even with advances in medical management of the disease. Despite the pervasiveness of this problem, most adolescents receive no training in the strategies that can help empower them to reduce pain and disability. The Internet offers a unique opportunity to reach adolescents with JIA and provide the training in pain self-management strategies that otherwise may not occur due to treatment access and resource obstacles.
Objective: To conduct a definitive test of an investigator-developed online coping skills training program for English and Spanish-speaking adolescents with JIA in the United States.
Design: A randomized controlled trial with repeated measures. Procedure: 360 English and Spanish speaking adolescents (12 to 18 years of age) with JIA are being recruited from 10 rheumatology clinics in the United States. Participants will then be randomized to either the experimental intervention (‘Teens Taking Charge’) or an attention control group. Participants in both groups will be called monthly over the three-month study period. Outcome measures will be collected at baseline and three, six, and 12 month follow-up periods.
Co-Investigator(s): Campillo, S, Dancey, P, Duffy, C, Ellsworth, J, Feldman, B, Fuss, S, Hetherington, R, Huber, A, Johnson, N, McGrath, P, Oen, K, Rosenberg, A, Spiegel, L, Tse, S, Tucker, L, Victor, C.
Funded by: Canadian Institutes of Health Research (CIHR); 2011-2014
Background: Juvenile idiopathic arthritis (JIA) is a common chronic childhood illness that is associated with physical (pain) and emotional (anxiety and depression) symptoms that can negatively impact health-related quality of life (HRQL). An adolescent with JIA is expected to have greater involvement in self-management as they mature. However most adolescents do not receive comprehensive education about JIA and strategies to manage their disease. Internet interventions provide an innovative approach to improve the accessibility and acceptability of self-management programs for adolescents with chronic illness.
Objective: To demonstrate the effectiveness of the ‘Teens Taking Charge: Managing JIA Online’ Internet intervention in improving pain and HRQL as well as other health outcomes.
Design: A multi-centred randomized control trial with repeated measures.
Procedure: 294 English and French speaking adolescents (12 to 18 years of age) with JIA are being recruited from ten rheumatology clinics across Canada. Adolescents and one of their parents will complete baseline measures. Participants will then be randomized to either the experimental intervention (‘Teens Taking Charge’) or an attention control group. Participants in both groups will be called monthly over the three-month study period. Outcome measures will be collected at baseline and three, six, and 12 month follow-up periods.
Co-Investigator(s): Bell, M, Kaufman, M, Spiegel, L, Luca, N, Amaria, K, Forgeron, P, Ahola Kohut, S
Funded by: Canadian Institutes of Health Research (CIHR); 2013-2014
Background: Juvenile idiopathic arthritis (JIA) is a common chronic childhood illness associated with difficulties in social and role functioning as well as physical and emotional symptoms that can negatively impact health-related quality of life (HRQL). Greater involvement in self-management could prevent worsening of the disease and symptoms, and facilitate successful transition to adult care. Providing peer support via Internet interventions (Skype) is an innovative approach to improve the accessibility and acceptability of self-management programs for youth with JIA.
Objective: To determine the feasibility of the “JIA Virtual Peer-to-Peer (VP2P) support program” on health outcomes and HRQL of adolescents with JIA using a phased approach
Design: A waitlist randomized control trial with a sample size of 40 participants will be used to test the feasibility and impact of the VP2P support program intervention for adolescents with JIA.
Procedure: Participants are being recruited from the paediatric rheumatology clinic at SickKids and randomized into one of two online peer support intervention groups (experimental and control groups). The study takes place over two months and online questionnaires will be completed at baseline and study endpoint.
Co-Investigator(s): Husain, A, Nathan, P, Gupta, A, Chong, AL, Hodgson, D, D’Agostino, N, Caffazzo, J, Jamieson, T.
Funded by: Canadian Institutes of Health Research (CIHR); 2013-2014
Background: Cancer is the most common cause of disease-related death in Canadian children. Adolescents and young adults with cancer (AYAC) are considered medically complex meaning they have high service needs and healthcare use. Web-based technologies offer a solution that may be effective in facilitating engagement of AYAC to promote disease self-management and optimize transitional care (i.e., coordination of their care) as they are early adopters of this technology.
Objective: To develop and evaluate an online communication tool for AYAC using a phased approach.
Design: A qualitative usability testing approach with semi-structured will be undertaken in iterative cycles to determine the usability and intuitiveness of the user interface of the online communication tool and refine the prototype.
Procedure: Participants will be recruited from the cancer clinics at The Hospital for Sick Children and Mount Sinai Hospital. Participants will then take part in a 60-minute semi-structured interview where they will be asked to ‘think out loud’ as they complete a set of standardized tasks (functionality, navigation etc.) on the communication portal platform. In future cycles of testing, participants may have the option of using the platform with their team of health care providers to determine the usability of the tool in an everyday work environment. The tool will then be refined based on the feedback.
Co-Investigator(s): Ruskin, D, Campbell, F, Forferon, P, Ahola Kohut, S.
Funded by: Investigator funded
Background: Chronic pain in children and adolescents is a common problem. Unrelieved or undertreated chronic pain can negatively impact all aspects of health-related quality of life (HRQL). Adolescence is a sensitive period for developing one’s sense of self, which often occurs in the context of peer relationships. However, this process is disrupted in adolescents with chronic pain as they try to manage their symptoms. Adolescents with chronic pain conditions may perceive behaviours of their healthy friends as unsupportive in various social situations resulting in these adolescents feeling different from their peers. Increasing social supports for adolescents with chronic pain would be an essential endeavor as they may be particularly vulnerable to long-term social isolation.
Objective: To develop and examine the impact of a Virtual Peer-to-Peer (VP2P) support program on health outcomes and HRQL of adolescents with chronic pain using a phased approach.
Design: A waitlist randomized control trial with a sample size of 40 participants will be used to test the feasibility and impact of the VP2P support program intervention for adolescents with chronic pain.
Procedure: Participants are being recruited from the Pain Clinic at The Hospital for Sick Children and randomized into one of two online peer support intervention groups (experimental and control groups). The study takes place over two months and online questionnaires will be completed at baseline and study endpoint.
Co-Investigator(s): Dick, B, Sung, L, Gupta, A, Dettmer, E, Le May, S, Dupuis, F, Laverdière, C.
Funded by: Canadian Institutes of Health Research (CIHR); 2011-2013
Background: During their course of illness, adolescents with cancer will experience a myriad of physical and emotional symptoms related to the disease, invasive procedures, and or chemotherapy and radiation. These symptoms are highly distressing, are often poorly managed, and restrict physical and social interactions, which negatively impact quality of life and can challenge many different aspects of normative adolescent developmental tasks. Furthermore, youth with cancer need to be prepared to transition to adult or after care. However, there is no comprehensive online self-management and transitional care program for youth with cancer.
Objective: To develop and evaluate usability of the “Teens Taking Charge: Managing Cancer Online” Internet intervention that will help adolescents with cancer to better cope with their disease, improve their health related quality of life and enhance readiness to transition to adult health care.
Design: A usability testing study design with iterative cycles is being used to refine the website prototype.
Procedure: The program content has been developed by a team of experts across Canada and geared towards the needs of adolescents and parents as identified from previous semi-structured interviews and focus groups. The program will consist of 12 modules for youth and two modules for parents. Usability testing will be conducted with ten youth and one of their parents using iterative cycles to examine the ease of use and understanding of the site as well as to uncover any technical problems. We will also determine participants’ satisfaction with the program.
Co-Investigator(s): Blanchette, V. and Breakey, V.
Funded by: Canadian Hemophilia Society; 2011-2013
Background: Adolescents are expected to assume greater responsibility for disease management as they near adulthood. However, adolescents’ ability to assume care is not always optimal, threatening compliance and adversely impacting health-related quality of life. The vast majority of youth with hemophilia do not receive comprehensive self-management and transitional care programs. Internet interventions provide an innovative approach to improve the accessibility and acceptability of psycho-educational programs for youth with chronic illnesses. While Internet-based programs have been found to be effective, to our knowledge there has been no interactive Internet-based self-management and transitional care program developed for youth with hemophilia.
Objective: To develop and evaluate an Internet intervention (Teens Taking Charge: Managing Hemophilia Online) for youth with hemophilia that will provide knowledge, disease management and transition skills, and social support.
Design: A pilot randomized control trial with a sample size of 40 participants.
Procedure: Participants (both English and French-speaking) are being recruited and randomized into one of two Internet intervention groups (experimental and control groups). The participants will be given a secure password for the website and will be asked to go through the eight-week module, viewing one module per week. A weekly call from a health coach will help determine whether there were any issues with the website and if there were any questions regarding the content.
Co-Investigator(s): Cafazzo, J, Jibb, L, Maloney, A, Nathan, P, Stevens, B.
Funded by: CIHR; 2012-2013
Background: Pain is one of the most common and distressing symptoms reported by adolescents with cancer and negatively impacts their quality of life. Despite advancements in the amount and quality of pain assessment and management research, adolescents with pain due to cancer and/or its treatment continue to experience it being managed poorly. Achieving the best possible pain symptom management requires two-way communication between the patient and healthcare provider. Currently this process occurs during brief clinic visits or busy hospital admissions with little to no two-way communication occurring in the home setting. Adolescents with cancer may be more vulnerable at home as they may ignore or accept some changes in their pain that they consider to not warrant the hassle of reporting to healthcare providers. New approaches are required to capture the full extent of pain experienced and to promote home-based self-management in adolescents with cancer. In our previous research we have developed a new iPhone-based pain diary for youth with cancer called the Pain Squad and tested its feasibility and are currently evaluated the psychometric properties of this tool.
Design: A consensus conference will bring together leading experts in paediatric oncology and pain (i.e. authors of clinical practice guidelines, content experts), system software (i.e. Smartphone applications) experts and consumers, to develop: (1) consensus on the standardized self-care pain treatment algorithms and clinical support tools that should be employed on the Smartphone pain diary computerized clinical decision support systems (CDSS) and (2) a plan to develop the prototype and evaluate the usability, feasibility and effectiveness of this system on patient, provider and health services outcomes.
Funded by: C17 Children’s Cancer & Blood Disorders; 2010-2012
Background: Poor cancer pain management has been identified by the World Health Organization as a major global health problem. Pain is a common and distressing symptom for children and youth with cancer. The most commonly reported barriers to effective pain treatment are inadequate pain assessment and patient reluctance to report. There is no comprehensive multidimensional pain diary that allows for real time data capture.
Objectives: To determine the reliability and construct validity (including responsiveness) of the Pain Squad Cancer Pain Diary.
Design: A multi-center prospective study design with repeated measures is being used to test the reliability, construct validity and responsiveness of the newly develop iPhone based pain diary. The sample will include 135 participants between eight and 18 years of age who are undergoing cancer treatment and are experiencing pain.
Procedures: Participants are being recruited from outpatient clinics and inpatient units. Participants will be trained on how to use the iPhone to fill in the surveys. Surveys will be completed twice a day for two weeks (or three weeks for responsiveness testing) and at the end of the two or three-week study period there is an evaluation survey.
Funded by: The Canadian Arthritis Network; 2010-2011
Background: Juvenile idiopathic srthritis (JIA) is a common chronic childhood illness that can negatively impact quality of life. Disease management is often complex, requiring diverse multifaceted therapies over long periods of time that necessitate frequent monitoring. As they move into adult-oriented health-care systems, adolescents are expected to assume greater responsibility for disease management due to their growing independence and autonomy. However, there are no well-validated tools to help youth and clinicians determine readiness to transition to adult-based health care.
Objective: To develop and test a new tool to assess the readiness to move on (or transition) to adult healthcare in youth with JIA.
Design: A sequential phased approach is being used to develop and determine the face and content validity of the Racer for Adult Care in Rheumatology (RACER) tool. First, a systematic review was conducted of current transition measures. This review was used to inform a consensus conference with Pediatric Rheumatologists and Adolescent Medicine Experts as well as consumers. During the consensus conference the domains and items were generated of the RACER tool. In the final phase, a descriptive study design is being used to determine the face and content validity of the tool from the perspectives of youth with JIA.
Procedure: In the final phase adolescents with JIA are completing a socio-demographic information sheet and will participate in cognitive interviews with the research assistant to determine the face and content validity of the new tool.
Co-Investigator(s): Toupin April, K, Moher, D, Boon, H, Tugwell, P, Duffy, C.
Funded by: Networks of Centres of Excellence (NCE), Canadian Arthritis Network – Discovery Advancement Program; 2009-2011
Background: Juvenile idiopathic arthritis (JIA) is one of the most common childhood chronic illnesses and can negatively impact all aspects of quality of life. Its management often requires a multi-disciplinary treatment approach using a combination of medications, exercise and splints. Parents may seek complementary and alternative health care (CAHC), especially if they are not satisfied with conventional care. However, no well-validated measure currently exists to evaluate CAHC use in children with chronic health conditions.
Objective: To develop and evaluate the face and content validity and feasibility of a CAHC questionnaire for children and youth with JIA.
Design: A sequential phased approach is being used to develop and evaluate this new measure. First, a systematic review was conducted of current CAHC measures. This review was used to inform a consensus conference with experts from CAHC, paediatric rheumatologists and adolescent medicine experts as well as consumers. During the consensus conference the domains and items were generated. In the final phase, a descriptive study design is being used to determine the face and content validity of the tool from the perspectives of parents of children with JIA (n=20), youth (n=20) and health care providers (N=20).
Procedure: For the final phase, participants have been recruited from two rheumatology clinics and socio-demographic information is obtained. Participants (parents of younger children and youth) are being asked to complete a socio-demographic information sheet, and then the research assistant will conduct a cognitive interview to determine the face and content validity of the new tool.
Funded by: Canadian Arthritis Network SRID Grant; 2005-2006.
Objectives: To explore the self-management needs of adolescents with juvenile idiopathic arthritis and the acceptability of a web-based program of self-management aimed at improving quality of life.
Methods: A descriptive qualitative design was used. A convenience sample of 36 adolescents (male and female) who varied in age, disease onset subtype, and disease severity were recruited from four Canadian tertiary care paediatric centers. Individual (n=25) and three focus-group (n=11) interviews were conducted with adolescents using semi-structured interview guides. After each interview session, the audiotaped interview data were transcribed verbatim.
Results: Adolescents articulated how they developed effective self-management strategies through the process of “letting go” from others who had managed their illness (health care professionals, parents) and “gaining control” over managing their illness on their own. The two strategies that assisted in this process were gaining knowledge and skills to manage the disease and experiencing understanding through social support. Five further subthemes emerged around skills to manage the disease, including knowledge and awareness about the disease, listening to and challenging care providers, communicating with the doctor, managing pain, and managing emotions.
Conclusions: Adolescents were united in their call for more information, self-management strategies, and meaningful social support to better manage their arthritis. They believed that Web-based interventions were a promising avenue to improve accessibility and availability of these interventions.
Funded by: Trainee Start-Up Fund, The Hospital for Sick Children; 2003-2004
Background: Current approaches to evaluating pain in children with chronic arthritis suffer from methodological problems. A real-time data capture approach using electronic diaries has been proposed as a new standard for pain measurement. However, there is limited information available regarding the development and feasibility of this approach in children.
Objectives: The aim of the present study was to pilot test the e-Ouch electronic pain diary in terms of compliance and acceptability in adolescents with arthritis to further refine the prototype.
Methods: A descriptive study design – with two iterative phases of testing, modifying the prototype and retesting – was used. A purposive sample of 13 adolescents with mild to severe pain and disability was drawn from a large rheumatology clinic in a university-affiliated pediatric tertiary care centre in Canada over a four-week period in December 2004. Participants were signalled with an alarm to use the diary three times per day for a two-week period. Adolescents completed an electronic diary acceptability questionnaire.
Results: Overall mean compliance rates for phases one and two were 72.9 percent and 70.5 percent, respectively. Compliance was affected by the timing of data collection and technical difficulties. Children rated the diary as highly acceptable and easy to use. Phase one testing revealed aspects of the software program that affected compliance, which were subsequently altered and tested in phase two. No further technical difficulties arose in phase two testing.
Conclusions: Feasibility testing is a crucial first step in the development of electronic pain measures before use in clinical and research practice.
Co-Principal Investigators: Stevens, B and Stinson, J
Co-Investigator(s): Feldman, B, McGrath, PJ, Sidani, S, Streiner, D.
Funded by: UTCSP AstraZeneca Award; 2003-2004
Objectives: The aim of this study was to evaluate the usability of the e-Ouch electronic chronic pain diary in adolescents with juvenile idiopathic arthritis.
Methods: A qualitative usability testing approach with semi-structured, audiotaped interviews with two iterative cycles was used. A purposive sample of 10 adolescents per cycle was drawn from a rheumatology clinic in a university-affiliated paediatric tertiary care centre. Participants were provided with a brief demonstration of the diary and then asked to use the diary “thinking aloud” to record the pain they experienced: (1) when they woke up that morning, (2) during that afternoon, and (3) from the previous evening. Adolescents were then asked a series of open-ended questions addressing ease of use of the diary. Qualitative thematic analysis was used to generate categories and emerging themes from interview data.
Results: All of the adolescents stated the e-Ouch diary was very easy to learn, use, and understand and was satisfying to complete. Participants took less than nine minutes to complete all three of the diary entries with minimal errors. The usability evaluation revealed aspects of the interface that were suboptimal (eg, VAS slider) and impeded the performance of certain tasks. Adolescents generated ideas on how the diary interface could be improved.
Conclusions: A multifaceted usability approach provided important insight regarding the use of technology by adolescents with arthritis and, more specifically, for understanding how adolescents can more effectively use an electronic chronic pain diary.
Co-Principal Investigators: Nadia Luca, Jennifer Stinson
Co-Investigators:, April Elliott, Nicole Johnson, Lynn Spiegel, Karine Toupin-April, Dianne Mosher, Aranka Rosettis, Sara Ahola Kohut, Carolyn Johns
Funded by: CIORA; 2014-2017
Background: Teenagers with juvenile idiopathic arthritis (JIA) need to move from a paediatric to an adult health care facility when they approach the age of 18. This process is known as “transition”. Successful transition can be difficult for a number of reasons. Youth may have trouble managing their health autonomously; caregivers may have a hard time letting go of their children; and health care providers may not feel adequately trained to provide transitional care. Currently, there is no standardized approach to transitioning JIA patients in Canadian rheumatology centres.
Objective: To develop a “transition tool-kit” that can help teenagers prepare to move to an adult health care centre. We will ask youth with JIA, caregivers, and health care providers what they think is important to include in the tool-kit.
Procedure: A prospective qualitative design with semi-structured, audiotaped focus group interviews will be undertaken with adolescents and young adults with JIA, caregivers of youth with JIA, and paediatric and adult rheumatology HCP caring for patients with JIA. Participants will take part in a focus group and express their thoughts on what a “transition tool-kit” would consist of.
Status: Recruitment is currently ongoing.
*Please note that all studies below have been completed*
Co-Investigator(s): Luca, N, Feldman, B, Bayoumi, A, Beaton, D, Benseler, S, Campillo, S, LeBlanc, C.
Funded by: Networks of Centres of Excellence (NCE), Canadian Arthritis Network – Discovery Advancement Program; 2012-2013
Background: Pain is the most common symptom in children with juvenile idiopathic arthritis (JIA). Studies of health-related quality of life (HRQL) in children with JIA show that those with higher levels of pain experience more problems with physical, emotional and social functioning. Pain assessment is the cornerstone of effective management. However, it can be challenging because pain is a subjective and multidimensional phenomenon and measures should include the sensory, affective and evaluative dimensions.
Objective: To determine the reliability, construct validity and responsiveness of the SUPER-KIDZ measures for the assessment of pain in children (four to 18 years of age) with JIA.
Design: A prospective cohort study.
Procedure: 130 participants are being recruited from two metropolitan rheumatology clinics. A secure patient account will then be created on the SUPER-KIDZ website and study participants will complete the pain measure online. There are two study groups: (A) reliability of the tool will be determined in youth whose medical treatment is stable; and (B) construct validity and responsiveness will be determined using youth undergoing steroid joint injections. Group A will complete an online questionnaire that takes about two to three minutes in clinic and global rating of change in pain question using a paper format. They will also be asked to complete the same online questionnaire from home one week after their clinic visit. Group B will complete a set of paper questionnaires that will take about 20 to 30 minutes and an online questionnaire that takes about two to three minutes in clinic. They will also complete the same online questionnaire from home the day before their scheduled joint injection and seven, 14 and 21 days after the injection.
Co-Investigator(s): Barrera, M, Greenberg, M, Gupta, A, Jibb, L.
Funded by: Pediatric Oncology Group of Ontario; 2012-2013
Background: Within the paediatric cancer population, adolescents are one group who may be especially vulnerable to the impacts of a cancer diagnosis and its treatment. The adolescent period is a time fraught with major developmental and lifestyle changes. These adolescents may experience social isolation from peers, limited social opportunities to meet potential romantic partners and a lack of privacy for sexual expression and unsupervised time with peers. However, little is know about adolescents’ perceptions of body image, sexuality and dating relationship issues related to having cancer.
Objective: To develop and evaluate an online program to help adolescents with cancer to better understand and manage body image, sexuality and dating relationship issues related to cancer treatment.
Design: A qualitative study design will be used with a sample size of 40 adolescents and their parents/primary caregivers (40 parents/primary caregivers).
Procedure: Participants will be recruited from haematology/oncology inpatient and outpatient clinics. Participants will participate in individual interviews to explore the perceptions of adolescents with cancer regarding: (a) the impact of cancer treatment on their body image, sexuality and dating relationships; (b) their information needs around these areas; and (c) whether a web-based program would be a good way to meet these needs.
Co-Principal Investigators: Hunter, J and Stinson, J
Co-Investigator(s): Campbell F, Gueorgueiva V, Stevens B, Lowe M, Simmons B, Parker K, Tallett S.
Funded by: Pfizer Canada Inc.; 2010-2011
Objective: To evaluate the acceptability and feasibility of a five-week (1.5 to 2 hr/week) interprofessional pain clinical-education (PAIN-IPE) for health care trainees.
Methods: A convenience sample of pre-licensure trainees participating in a clinical placement at a paediatric tertiary hospital was recruited to participate. Participants completed pre- and post-placement questionnaires on paediatric pain knowledge, interdisciplinary education perceptions, and interprofessional education (IPE) competencies. Debriefing focus groups were conducted with participants and curriculum facilitators.
Results: Three iterative cycles took place with a total of 21 trainees from pharmacy, undergraduate nursing, social work, medicine, occupational therapy, physical therapy, child life, and graduate nursing participating. Overall, trainees felt the placement was beneficial and the experience changed their perception of their own roles and the roles of other professions in managing pain in children. Trainees liked the structure of the tutorials, the patient-centred care approach, and the student-directed learning. Following completion of the first and second cycles, suggestions from the trainees and facilitators on how the program could be improved were incorporated into the third cycle. Participants were pleased with the balance of pain and interprofessional curriculum. Facilitators felt that this placement would be best delivered to senior level trainees who have previous clinical experience.
Conclusion: A five-week PAIN-IPE for trainees is both acceptable and feasible for implementation in a paediatric tertiary hospital. Future research investigating the acceptability and feasibility in an adult care setting is required to further the generalizability of these findings.
Co-Investigator(s): Fiona Campbell, Lisa Isaac, Stephen Brown, Jennifer Tyrrell, Dnaielle Ruskin, Michael Jeavons, Anne Ayling Campos, Chitra Lalloo
Funded by: Church & Dwight Foundation
Background: The Canadian Community Health Survey found that approximately one in 10 Canadians aged 12 to 44 years suffer from chronic pain and that the prevalence of pain increased with age and had a negative impact on activities of daily living, work-related activities, and psychological well-being. Youth with chronic pain often resort to using over-the-counter (OTC) oral and topical medications while they are seeking treatment for persistent pain. What is not known is what OTC oral and topical pain treatments are being used by youth with chronic pain, their decision-making around use of these products, and how they communicate with their health care providers about their use.
Objective: The purpose of this study is to explore the use, decision-making process and communication about the use of OTC pain medication products with health care professionals in adolescents suffering from chronic pain and their primary caregiver.
Procedure: A prospective descriptive qualitative design with semi-structured, audiotaped individual interviews will be undertaken with children and adolescents with chronic pain and their primary caregiver to understand the use of OTC pain treatments including oral and topical analgesics to manage pain. We will conduct individual interviews with children and adolescents with chronic pain and their primary caregiver regarding their use, choices and communication surrounding OTC pain medications.
Co-Investigator(s): Gary Walco, Marsha Campbell, Christine Lamontagne
Funded by: Investigator Funded
Background: Children with chronic pain experience a myriad of physical, emotional, social, cognitive, and role functioning symptoms and problems. Early pain management intervention can reduce pain duration, pain-related disability, and thus healthcare costs. However, recent surveys have revealed unacceptably high levels of under treatment and intolerably long wait-times to access appropriate chronic pain care in Canada. To begin to address these inequities in access to care, the Ontario Ministry of Health and Long-Term Care (MOHLTC) has formed a Paediatric Chronic Pain Network Task Force, the mandate of which is to develop a comprehensive strategy to put systems in place to provide evidence-based care for children and youth with chronic pain, including creating a Canadian Paediatric Chronic Pain Registry.
Objective: To determine the feasibility of the paediatric pain registry forms from the perspectives of the end users in a paediatric pain clinic in Ontario. Information learned from this study will be used to refine the prototype.
Procedure: A prospective mixed method study design will be used to test the feasibility of the Canadian Paediatric Pain Registry forms. Twenty to thirty consenting English-speaking children/adolescents and one of their parents/caregivers from a large metropolitan tertiary hospital will be recruited and asked to complete the registry forms and participate in a brief individual interview following completion of the online forms to understand their perceptions of the feasibility of completing the forms. We will conduct 10 interviews and then analyze the data to refine the registry forms and then we will conduct another cycle of testing. We anticipate two to three cycles of testing.
Status: Refinements currently being made to registry after two iterations of testing.