Teens Taking Charge: A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 6
- 主要终点
- Participant Accrual and Dropout Rates
研究概览
简要总结
Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education, self-monitoring capabilities, and social support to enhance disease self-management by adolescents with cancer. While two interactive coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not focus on helping youth gain skills for transition and independence, and (3) do not provide opportunities for meaningful social support. In summary, there is a crucial need to develop a comprehensive interactive Internet-based self-management program targeting AWC that is comprised of cancer education, self-management skills, and opportunities for social support, and that is cost-effective.
详细描述
Overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Cancer Online" Internet intervention that will help AWC to better cope with their disease, improve their HRQL, and enhance readiness to transition to adult health care using a sequential phased approach. The first phase of this project has determined the self-management and transitional care needs of adolescents with cancer. The second phase consisted of website development and usability testing to ensure the website is easy to use and understand, and is efficient and satisfying to complete. Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3). This will inform the design and methods of the main trial, and will permit us to obtain estimates of treatment effects on AWC health outcomes to inform the calculation of an appropriate sample size for the future definitive RCT (Phase 4). The focus of this study is Phase 3. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents and adolescents will be eligible to participate if the adolescents are:
- •between 12-18 years of age
- •diagnosed with cancer (at least 3 months from diagnosis)
- •on active treatment
- •able to speak and read English and/or French at a Grade 6 level
排除标准
- •Adolescents will be excluded if they:
- •have major cognitive impairments
- •have reduced executive function that may impact their ability to understand and use the online program
- •are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)
研究组 & 干预措施
Taking Charge Experimental Group
干预措施: Taking Charge: Managing Cancer Online (Behavioral)
Control Group
干预措施: Standard Medical Care and Cancer Resource Center (Behavioral)
结局指标
主要结局
Participant Accrual and Dropout Rates
时间窗: 12 weeks
These rates will be centrally tracked by the Clinical Research Project Coordinator
Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)
时间窗: 12 weeks
Post-treatment, adolescents with cancer and their parents in the intervention group will rate their acceptability of and satisfaction with the intervention
Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)
时间窗: 12 weeks
Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the Clinical Research Project Coordinator
Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)
时间窗: 12 weeks
Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents
次要结局
- Knowledge (Adolescent Cancer Knowledge Questionnaire)(12 weeks)
- Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)(12 weeks)
- Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)(12 weeks)
- Treatment adherence (Medication Adherence Scale)(12 weeks)
- Transition readiness (Cancer Transition Scales)(12 weeks)
- Health Related Quality of Life (PedsQL Cancer Module)(12 weeks)
- Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)(12 weeks)
- Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)(12 weeks)
- Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)(12 weeks)
研究者
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children