Teens Taking Charge: Managing Cancer Online

NCT ID: NCT02299219

Last Updated: 2019-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-04-01

Brief Summary

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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

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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

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Taking Charge Experimental Group

Group Type EXPERIMENTAL

Taking Charge: Managing Cancer Online

Intervention Type BEHAVIORAL

n 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.

Control Group

Group Type ACTIVE_COMPARATOR

Standard Medical Care and Cancer Resource Center

Intervention Type BEHAVIORAL

The 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.

Interventions

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Taking Charge: Managing Cancer Online

n 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.

Intervention Type BEHAVIORAL

Standard Medical Care and Cancer Resource Center

The 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Montréal

OTHER

Sponsor Role collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Stinson

Clinician Scientist, Clinical Nurse Specialist/NP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer N Stinson, PhD, CPNP

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status

Children's Hospital Eastern Ontario

Ottawa, Ontario, Canada

Site Status

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000045896

Identifier Type: -

Identifier Source: org_study_id

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