Teens Taking Charge: Managing Cancer Online

NCT02299219 | Completed

• 1 other identifier: 1000045896
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Adolescent; Internet Self-Management; Managing Cancer

Outcome Measures

Primary Outcomes (4)

• Participant Accrual and Dropout Rates

  These rates will be centrally tracked by the Clinical Research Project Coordinator

  12 weeks

• Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)

  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

  12 weeks

• Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)

  Post-treatment, adolescents with cancer and their parents in the intervention group will rate their acceptability of and satisfaction with the intervention

  12 weeks

• Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)

  Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents

  12 weeks

Secondary Outcomes (10)

• Knowledge (Adolescent Cancer Knowledge Questionnaire)

  12 weeks

• Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)

  12 weeks

• Treatment adherence (Medication Adherence Scale)

  12 weeks

• Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)

  12 weeks

• Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)

  12 weeks

Study Arms (2)

Taking Charge Experimental Group

EXPERIMENTAL

Behavioral: Taking Charge: Managing Cancer Online

Control Group

ACTIVE COMPARATOR

Behavioral: Standard Medical Care and Cancer Resource Center

Interventions

Taking Charge: Managing Cancer Online 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.

Taking Charge Experimental Group

Standard Medical Care and Cancer Resource Center 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.

Control Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Université de Montréal: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• St. Justine's Hospital: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Institute for Clinical Evaluative Sciences: collaborator
• McGill University: collaborator
• McMaster University: collaborator
• University of Alberta: collaborator

Study Sites (3)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

Children's Hospital Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jennifer N Stinson, PhD, CPNP

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Clinical Nurse Specialist/NP

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

CA (3)