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Completed

NCT Number: NCT02915471

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Accrual and Attrition rates

    Time frame: 2 months

  2. Adherence

    Time frame: 2 months

    100% if calls completed over 10 weeks

  3. Proportion of completed questionnaires

    Time frame: 2 months

    100% if all questions completed

  4. Technical difficulties - developed by the investigator

    Time frame: 2 months

    Date, time and issue will be collected

  5. Acceptability - semi structured interviews with AWC and mentors

    Time frame: 2 months

    Semi-structured interviews will be developed by the investigator

Secondary outcomes

  1. Health Related Quality of Life (HRQL)

    Time frame: 2 months

    Using PedsQL and its Cancer Module

  2. Knowledge

    Time frame: 2 months

    Using Adolescent Cancer Knowledge Questionnaire

  3. Perceived social support

    Time frame: 2 months

    Perceived Social Support from Friends

  4. Self-efficacy

    Time frame: 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.

  5. Transition readiness

    Time frame: 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

Other outcomes

  1. Frequency and content

    Time frame: 2 months

    The 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.

  2. Mentor physical and emotional symptoms SF-36 physical and mental scales

    Time frame: 2 months

    Effect sizes for mentor physical and emotional symptoms (using SF-36 physical and mental scales)

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

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2016
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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