Clinical trial NCT02915471: Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Cancer
Official title: Virtual Peer-to-peer (VP2P) Support Mentoring for Adolescents With Cancer: A Pilot Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Adolescent
Online Peer Support
Managing Cancer
Mentor
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Accrual and Attrition rates
timeFrame: 2 months
measure: Adherence
timeFrame: 2 months
measure: Proportion of completed questionnaires
timeFrame: 2 months
measure: Technical difficulties - developed by the investigator
timeFrame: 2 months
measure: Acceptability - semi structured interviews with AWC and mentors
timeFrame: 2 months
Secondary outcomes:
measure: Health Related Quality of Life (HRQL)
timeFrame: 2 months
measure: Knowledge
timeFrame: 2 months
measure: Perceived social support
timeFrame: 2 months
measure: Self-efficacy
timeFrame: 2 months
measure: Transition readiness
timeFrame: 2 months
Other outcomes:
measure: Frequency and content
timeFrame: 2 months
measure: Mentor physical and emotional symptoms SF-36 physical and mental scales
timeFrame: 2 months
measure: Mentor perceived social role satisfaction - PROMIS Satisfaction with Social Roles and Activities
timeFrame: 2 months
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References: