Clinical trial NCT04075734: Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult 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: Childhood Cancer Survivors
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project is to evaluate the feasibility of the "Managing Your Health" online self-management skills+peer mentoring intervention that focuses on overcoming survivor barriers to self-management of their survivorship care. We will conduct a pilot randomized controlled trial (RCT) of the intervention versus usual care with adolescent and young adult survivors of childhood cancer ages 18-25 years. Participants will complete survey measures at baseline, Time 2 (about 2 months after baseline), Time 3 (about 5 months after baseline), and Time 4 (about 12 months after baseline).

Detailed description: PRIMARY OBJECTIVES:

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

II. Assess preliminary efficacy of the intervention.

Eligibility criteria: Inclusion Criteria:

Young Adult Survivors:

* age 18-25;
* at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
* low self-reported responsibility for healthcare as indicated by reporting parent is primarily responsible for healthcare or low score (1 or 2) on two or more items from Readiness for Transition Questionnaire - Survivor Version.

Peer Mentor:

* age 21-29;
* at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
* self-reported primary responsibility for healthcare and "complete" readiness to assume responsibility or high scores (3 or 4) on all items from Readiness for Transition Questionnaire - Survivor Version.

Exclusion Criteria:

• Documented or self-reported cognitive delay to prevent self-management of healthcare.

Primary outcomes:
measure: Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline
timeFrame: Baseline
measure: Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up
timeFrame: Time 3 at about 5 months since Baseline.
measure: Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage
timeFrame: Time 2, about 2 months since baseline.
measure: Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean
timeFrame: Time 2, about 2 months since baseline.
measure: Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
timeFrame: Time 2, about 2 months since baseline.
measure: Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
timeFrame: Time 2, about 2 months since baseline.
measure: Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire
timeFrame: Time 2, about 2 months since baseline.
measure: Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire
timeFrame: Time 2, about 2 months since baseline
Secondary outcomes:
measure: Healthcare Responsibility (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Knowledge (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
measure: Self-Management Skills/Self-Efficacy (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
measure: Self-Management Goals (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
measure: Self-Management Beliefs (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
measure: Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Health Insurance Self-efficacy (Young Adult Survivors): Scale
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Survivorship Care Attitudes (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Self-efficacy for Managing Emotions (Young Adult Survivors): Scale
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
measure: Emotional Support (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
measure: Informational Support (Young Adult Survivors)
timeFrame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Other outcomes:
measure: Healthcare Utilization (Young Adult Survivors)
timeFrame: Baseline, Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Inst. of NJ
name: Katie Devine, PhD
role: PRINCIPAL_INVESTIGATOR
References: