Clinical trial NCT02299219: Teens Taking Charge: Managing Cancer Online
Official title: Teens Taking Charge: A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Adolescent
Internet Self-Management
Managing Cancer
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: Children's Hospital of Eastern Ontario
name: St. Justine's Hospital
name: Hamilton Health Sciences Corporation
name: Institute for Clinical Evaluative Sciences
name: McGill University
name: McMaster University
name: University of Alberta
First posted: 2014-11-24
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Participant Accrual and Dropout Rates
timeFrame: 12 weeks
measure: Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)
timeFrame: 12 weeks
measure: Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)
timeFrame: 12 weeks
measure: Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)
timeFrame: 12 weeks
Secondary outcomes:
measure: Knowledge (Adolescent Cancer Knowledge Questionnaire)
timeFrame: 12 weeks
measure: Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)
timeFrame: 12 weeks
measure: Treatment adherence (Medication Adherence Scale)
timeFrame: 12 weeks
measure: Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)
timeFrame: 12 weeks
measure: Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)
timeFrame: 12 weeks
measure: Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)
timeFrame: 12 weeks
measure: Transition readiness (Cancer Transition Scales)
timeFrame: 12 weeks
measure: Health Related Quality of Life (PedsQL Cancer Module)
timeFrame: 12 weeks
measure: Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital Eastern Ontario
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer N Stinson, PhD, CPNP
role: PRINCIPAL_INVESTIGATOR
References: