Virtual Peer-to-peer (VP2P) Support Mentoring for Adolescents With Cancer: A Pilot Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Accrual and Attrition rates
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Virtual Peer-to-Peer Support Mentoring
n addition to standard medical care, adolescents in the experimental group will receive the iP2P support program, a manualized peer-mentorship program that will provide mentoring and reinforcement by peers (young adults with cancer aged 16-25 years who have learned to function successfully with their cancer to the mentored participants).
Intervention: Virtual Peer-to-Peer Support Mentoring (Behavioral)
Wait-list Control
The control group will receive usual care but without the mentorship intervention. They will be offered the iP2P support program after completion of outcome measures (T1 - to be completed online prior to randomization; T2 - at program completion).
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)
Investigators
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/ NP
The Hospital for Sick Children