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

NCT02915471 | Completed

• 1 other identifier: 1000051755
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Adolescent; Online Peer Support; Managing Cancer; Mentor

Outcome Measures

Primary Outcomes (5)

• Accrual and Attrition rates

  2 months

• Adherence

  100% if calls completed over 10 weeks

  2 months

• Proportion of completed questionnaires

  100% if all questions completed

  2 months

• Technical difficulties - developed by the investigator

  Date, time and issue will be collected

  2 months

• Acceptability - semi structured interviews with AWC and mentors

  Semi-structured interviews will be developed by the investigator

  2 months

Secondary Outcomes (5)

• Health Related Quality of Life (HRQL)

  2 months

• Knowledge

  2 months

• Perceived social support

  2 months

• Self-efficacy

  2 months

• Transition readiness

  2 months

Other Outcomes (3)

• Frequency and content

  2 months

• Mentor physical and emotional symptoms SF-36 physical and mental scales

  2 months

• Mentor perceived social role satisfaction - PROMIS Satisfaction with Social Roles and Activities

  2 months

Study Arms (2)

Virtual Peer-to-Peer Support Mentoring

EXPERIMENTAL

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).

Behavioral: Virtual Peer-to-Peer Support Mentoring

Wait-list Control

NO INTERVENTION

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).

Interventions

Virtual Peer-to-Peer Support Mentoring BEHAVIORAL

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).

Virtual Peer-to-Peer Support Mentoring

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Clinical Nurse Specialist/ NP

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 27, 2016
• Study Start: August 1, 2016
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

CA (1)