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CancerNCT02915471

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

A study testing Virtual Peer-to-Peer Support Mentoring in people with Cancer, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Cancer
What is being tested?
Virtual Peer-to-Peer Support Mentoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteCanada
Study dates
Aug 2016to 30 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Cancer
Being tested
Virtual Peer-to-Peer Support Mentoring
Keywords
Adolescent, Online Peer Support, Managing Cancer, Mentor
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Peer-to-Peer Support MentoringBehavioural

    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).

Study groups in NCT02915471
Study groupRoleWhat they receive
Virtual Peer-to-Peer Support MentoringExperimentaln 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).
Receives: Behavioral: Virtual Peer-to-Peer Support Mentoring
Wait-list ControlNo interventionThe 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual and Attrition rates

    Measured: 2 months

  2. Adherence

    100% if calls completed over 10 weeks

    Measured: 2 months

  3. Proportion of completed questionnaires

    100% if all questions completed

    Measured: 2 months

  4. Technical difficulties - developed by the investigator

    Date, time and issue will be collected

    Measured: 2 months

  5. Acceptability - semi structured interviews with AWC and mentors

    Semi-structured interviews will be developed by the investigator

    Measured: 2 months

Secondary outcomes (5)

  1. Health Related Quality of Life (HRQL)

    Using PedsQL and its Cancer Module

    Measured: 2 months

  2. Knowledge

    Using Adolescent Cancer Knowledge Questionnaire

    Measured: 2 months

  3. Perceived social support

    Perceived Social Support from Friends

    Measured: 2 months

  4. 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. α = 0.87 Validity: Evidence of good construct validity as positively correlated with Rosenberg Self-Esteem Scale.

    Measured: 2 months

  5. Transition readiness

    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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02915471
Sponsor's protocol ID
1000051755
Status last verified
Oct 2019
First submitted
12 Sep 2016
Last updated
11 Oct 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Peer-to-Peer Support Mentoring in people with Cancer, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual and Attrition rates (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02915471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.

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