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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02915471
Enrollment
37
Registered
2016-09-27
Start date
2016-08-31
Completion date
2019-08-30
Last updated
2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Adolescent, Online Peer Support, Managing Cancer, Mentor

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.

Interventions

The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 45 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 1.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability - semi structured interviews with AWC and mentors2 monthsSemi-structured interviews will be developed by the investigator
Proportion of completed questionnaires2 months100% if all questions completed
Technical difficulties - developed by the investigator2 monthsDate, time and issue will be collected
Accrual and Attrition rates2 months
Adherence2 months100% if calls completed over 10 weeks

Secondary

MeasureTime frameDescription
Self-efficacy2 monthsGeneralized 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.
Health Related Quality of Life (HRQL)2 monthsUsing PedsQL and its Cancer Module
Knowledge2 monthsUsing Adolescent Cancer Knowledge Questionnaire
Perceived social support2 monthsPerceived Social Support from Friends
Transition readiness2 monthsTransition-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

Other

MeasureTime frameDescription
Frequency and content2 monthsThe nature (frequency and content) of the emotional, appraisal and informational support provided by mentors during VP2P sessions will be established. Data for this outcome will be collected from the audio-recorded Skype calls and text messages from each AWC-mentor dyad.
Mentor perceived social role satisfaction - PROMIS Satisfaction with Social Roles and Activities2 months
Mentor physical and emotional symptoms SF-36 physical and mental scales2 monthsEffect sizes for mentor physical and emotional symptoms (using SF-36 physical and mental scales)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026