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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915471
• Other study ID #: 1000051755
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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).

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency and content	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 months
Other	Mentor physical and emotional symptoms SF-36 physical and mental scales	Effect sizes for mentor physical and emotional symptoms (using SF-36 physical and mental scales)	2 months
Other	Mentor perceived social role satisfaction - PROMIS Satisfaction with Social Roles and Activities		2 months
Primary	Accrual and Attrition rates		2 months
Primary	Adherence	100% if calls completed over 10 weeks	2 months
Primary	Proportion of completed questionnaires	100% if all questions completed	2 months
Primary	Technical difficulties - developed by the investigator	Date, time and issue will be collected	2 months
Primary	Acceptability - semi structured interviews with AWC and mentors	Semi-structured interviews will be developed by the investigator	2 months
Secondary	Health Related Quality of Life (HRQL)	Using PedsQL and its Cancer Module	2 months
Secondary	Knowledge	Using Adolescent Cancer Knowledge Questionnaire	2 months
Secondary	Perceived social support	Perceived Social Support from Friends	2 months
Secondary	Self-efficacy	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. a = 0.87 Validity: Evidence of good construct validity as positively correlated with Rosenberg Self-Esteem Scale.	2 months
Secondary	Transition readiness	Transition-Q Readiness scale will be used to measure transition readiness. Reliability: Internal consistency good, a = 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	2 months