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

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ClinicalTrials.gov Identifier: NCT02915471
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Stinson, 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Virtual Peer-to-Peer Support Mentoring Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Virtual Peer-to-peer (VP2P) Support Mentoring for Adolescents With Cancer: A Pilot Pragmatic Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: 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).
Behavioral: Virtual Peer-to-Peer Support Mentoring
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).

No Intervention: 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).



Primary Outcome Measures :
  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 Outcome Measures :
  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. Treatment adherence [ Time Frame: 2 months ]
    Morisky Medication-Taking Adherence Scale

  5. Self-efficacy [ Time Frame: 2 months ]
    Generalized Self-Efficacy Sherer Scale

  6. Transition readiness [ Time Frame: 2 months ]
    Transition-Q


Other Outcome Measures:
  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 ]


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915471


Contacts
Contact: Jennifer N Stinson, RN, PhD, CPNP jennifer.stinson@sickkids.ca

Locations
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Vanessa Hum, BSc    4168137654 ext 302313    vanessa.hum@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children

Responsible Party: Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/ NP, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02915471     History of Changes
Other Study ID Numbers: 1000051755
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Keywords provided by Jennifer Stinson, The Hospital for Sick Children:
Adolescent
Online Peer Support
Managing Cancer
Mentor