Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Cancer

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Virtual Peer-to-Peer Support Mentoring

• Registration Number: NCT02915471
• Lead Sponsor: The Hospital for Sick Children

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Peer-to-Peer Support Mentoring	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).

Primary Outcome Measures

Name	Time	Method
Accrual and Attrition rates	2 months
Technical difficulties - developed by the investigator	2 months	Date, time and issue will be collected
Adherence	2 months	100% if calls completed over 10 weeks
Proportion of completed questionnaires	2 months	100% if all questions completed
Acceptability - semi structured interviews with AWC and mentors	2 months	Semi-structured interviews will be developed by the investigator

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life (HRQL)	2 months	Using PedsQL and its Cancer Module
Self-efficacy	2 months	Generalized Self-Efficacy Sherer Scale will be used to measure self-efficacy where 1 = not true and 4 = exactly true.; Reliability: Internal consistency is good for adolescents. α = 0.87 Validity: Evidence of good construct validity as positively correlated with Rosenberg Self-Esteem Scale.
Transition readiness	2 months	Transition-Q Readiness scale will be used to measure transition readiness. Reliability: Internal consistency good, α = 0.87. Test-retest reliability = 0.90 Validity: Construct validity supported by scores for transition readiness being lower for younger children (p \< 0.01) and those who needed assistance completing the scale (p \< 0.01). Scores were incrementally higher according to agreement with the statement, "I am ready to transfer to adult health care" (p \< 0.01).; Scale options are from 0 to 2; 0 = never, 1 = sometimes, 2 = always. A higher score refers to higher transition readiness
Perceived social support	2 months	Perceived Social Support from Friends
Knowledge	2 months	Using Adolescent Cancer Knowledge Questionnaire

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada