Teens Taking Charge: Managing Cancer Online

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Standard Medical Care and Cancer Resource Center

• Registration Number: NCT02299219
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Study Start: 2016-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Parents and adolescents will be eligible to participate if the adolescents are:

  1. between 12-18 years of age
  2. diagnosed with cancer (at least 3 months from diagnosis)
  3. on active treatment
  4. able to speak and read English and/or French at a Grade 6 level

Exclusion Criteria

• Adolescents will be excluded if they:

  1. have major cognitive impairments
  2. have reduced executive function that may impact their ability to understand and use the online program
  3. are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Medical Care and Cancer Resource Center	-

Primary Outcome Measures

Name	Time	Method
Participant Accrual and Dropout Rates	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)	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)	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)	12 weeks	Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents

Secondary Outcome Measures

Name	Time	Method
Knowledge (Adolescent Cancer Knowledge Questionnaire)	12 weeks	Measured using the Adolescent Cancer Knowledge Questionnaire, a 15-item tool that assesses cancer-specific knowledge.
Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)	12 weeks	Measured by the Generalized Self-Efficacy-Sherer Scale, a 12-item scale that requires adolescents to indicate their level of agreement with a series of statements about self-efficacy.
Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)	12 weeks	Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for individuals aged \>12 years, which can be completed within 2-5 minutes.
Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)	12 weeks	Measured with the Perceived Social Support from Friends (PSS-Fr) Scale, a 20-item scale that assesses the extent to which an individual perceives that their friends fulfill their needs for support.
Treatment adherence (Medication Adherence Scale)	12 weeks	Measured with the Medication Adherence Scale, a 4-item scale for assessing self-reported adherence.
Transition readiness (Cancer Transition Scales)	12 weeks	Measured with the Cancer Transition Scales, which include sub-scales for 'cancer worry' (6 items), 'self-management skills' (15 items), and 'expectations' (12 items).
Health Related Quality of Life (PedsQL Cancer Module)	12 weeks	measured with the PedsQL Cancer Module, a 27-item scale, which has validated versions for child, teen, and parental report, and the Health Utility Index \[HUI\].
Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)	12 weeks	Measured by ascertaining direct health care costs and family out of pocket costs related to cancer care incurred over the 12-week study period using the Health Care Utilization form modified from the Ambulatory and Home Care Record84-90 as well as direct costs related to the online intervention technology, intervention training and personnel. Quality adjusted life years will be calculated using the HUI to determine the incremental cost-effectiveness
Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)	12 weeks	Measured using the short form Brief Pain Inventory (BPI), a 15-item measure that includes scales for measuring pain intensity, impact of pain on functioning and well being, and pain interference.
Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)	12 weeks	Measured using the PedsQL Multidimensional Fatigue Module, an 18-item scale with validated versions for child report (ages 8-12 years), teen report (ages 13-18 years), and parental report for children and teens.

Trial Locations

Locations (3)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada