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Clinical Trials/NCT02915471
NCT02915471
Completed
Not Applicable

Virtual Peer-to-peer (VP2P) Support Mentoring for Adolescents With Cancer: A Pilot Pragmatic Randomized Controlled Trial

The Hospital for Sick Children1 site in 1 country37 target enrollmentAugust 2016
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
The Hospital for Sick Children
Enrollment
37
Locations
1
Primary Endpoint
Accrual and Attrition rates
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The overall aim of this research program is to develop and examine the impact of a Cancer virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the Skype-based VP2P program providing peer-support from mentors and the magnitude of program effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT will enable us to refine the program and determine the appropriate sample size for a future large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at a major Children's Oncology Group- affiliated centers in Canada and the United States.

Detailed Description

The aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with cancer using a waitlist randomized controlled trial. In addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modelling and reinforcement by trained young adults aged 18-25 years who have learned to function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
August 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Stinson

Clinician Scientist, Clinical Nurse Specialist/ NP

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • English-speaking 12-17 year olds
  • Cancer diagnosis with an expected 5-year survival rate of \>70% according to treating oncologist (most childhood cancer diagnoses meet this criterion1)
  • Access to computer capable of using free Skype software (NB: 87% of American households had Internet access in)
  • Karnofsky or Lansky performance status of 60/100 (minimal assistance needed to complete activities) as assessed by the study coordinator at the time of recruitment. The Principal Investigator and Co-Investigators (Dr. Jennifer Stinson, Dr. Nathan and Dr. Gupta) will train the study coordinator to complete Karnofsky or Lansky performance assessments.
  • NB. Note that even though text messaging is part of the intervention, access to smartphones is not required. Smartphones (iPhone 6) may be loaned to participants by Dr. Stinson.

Exclusion Criteria

  • Significant cognitive impairment or major co-morbid illness as identified by their treating oncologist
  • Participation in other peer support or self-management programs
  • Receiving end-of-life care

Outcomes

Primary Outcomes

Accrual and Attrition rates

Time Frame: 2 months

Technical difficulties - developed by the investigator

Time Frame: 2 months

Date, time and issue will be collected

Adherence

Time Frame: 2 months

100% if calls completed over 10 weeks

Proportion of completed questionnaires

Time Frame: 2 months

100% if all questions completed

Acceptability - semi structured interviews with AWC and mentors

Time Frame: 2 months

Semi-structured interviews will be developed by the investigator

Secondary Outcomes

  • Health Related Quality of Life (HRQL)(2 months)
  • Self-efficacy(2 months)
  • Transition readiness(2 months)
  • Perceived social support(2 months)
  • Knowledge(2 months)

Study Sites (1)

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