Clinical Trials Directory

Trials / Completed

CompletedNCT02299219

Teens Taking Charge: Managing Cancer Online

Teens Taking Charge: A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
73 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTaking Charge: Managing Cancer Onlinen addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing Cancer Online" Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol that consists of Cancer-specific education, self-management strategies, and social support that is available in English and French.
BEHAVIORALStandard Medical Care and Cancer Resource CenterThe control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about Cancer ("Cancer Resource Centre") and online assessments.

Timeline

Start date
2016-01-01
Primary completion
2019-04-01
Completion
2019-04-01
First posted
2014-11-24
Last updated
2019-10-09

Locations

3 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT02299219. Inclusion in this directory is not an endorsement.