Clinical trial NCT02699996: Peer Mentoring in Promoting Follow-up Care Self-Management in Younger Childhood Cancer Survivors
Official title: Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Keywords: Cancer Survivor
Young Adult
Peer Mentor
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot trial studies a peer mentoring and online self-management program to see how well it works in promoting follow-up care self-management in younger childhood cancer survivors. Childhood cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors. A peer mentoring program + self-management may improve disease knowledge, health motivation, problem-solving skills, stress management, and communication with caregivers and providers in adolescent and young adult cancer survivors.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.

II. Assess preliminary outcomes of the peer mentoring program.

OUTLINE:

All Participants will be asked to complete online self-management educational modules and 6 weekly peer mentor calls to facilitate engagement with the online modules and offer specialized support. We will also recruit and train peer Mentors.

Eligibility criteria: Inclusion Criteria:

PEER MENTOR ELIGIBILITY:

* Age 21-29
* At least 1.5 years from treatment
* Self-reported primary responsibility for care and "complete readiness" using the Readiness for Transition Questionnaire

PATIENT ELIGIBILITY:

* Age 18-25
* At least 1.5 years from treatment
* Currently does not independently self-manage follow-up care according to self-report to assume total responsibility for care (i.e., reports low readiness \[score of 1 or 2 out of 4\] OR scores \<3 on any of the 10-item responsibility scale from the Readiness for Transition Questionnaire)

Exclusion Criteria:

PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare

Primary outcomes:
measure: Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out.
timeFrame: 6 weeks
measure: Satisfaction With Intervention, Measured by 1) General Satisfaction, 2) Intervention Utility Questionnaire, 3) Impact Questionnaire (i.e., Effectiveness), and 4) Adherence Questionnaire ( i.e., Barriers to Engagement).
timeFrame: 6 weeks (post-intervention)
measure: Mentor Training Satisfaction
timeFrame: Time of enrollment, after completing mentor training.
Secondary outcomes:
measure: Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version
timeFrame: Baseline to up to 6 weeks
measure: Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2).
timeFrame: Baseline to up to 6 weeks
measure: Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b).
timeFrame: Baseline to up to 6 weeks
measure: Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
timeFrame: Baseline to up to 6 weeks
measure: Cancer Related Worry Scale
timeFrame: Baseline to up to 6 weeks
measure: Short Grit Scale
timeFrame: Baseline to up to 6 weeks
measure: Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale
timeFrame: Baseline to up to 6 weeks
measure: Barriers to Follow-up Care & Adherence
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Katie Devine
role: PRINCIPAL_INVESTIGATOR
References: