N/A N=60 Randomized Supportive Care

Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors

Childhood Cancer Survivors

Bottom Line

View on ClinicalTrials.gov: NCT04075734 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline — 50; 29 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Managing Your Health: Self-Management + Peer Mentoring (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Rutgers, The State University of New Jersey
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline	50; 29	—
PRIMARY Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up	22; 25	—
PRIMARY Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage	95.72; 97.72	—
PRIMARY Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean	4.64; 4.41; 4.64; 2.00; 2.86	—
PRIMARY Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire	4.35	—
PRIMARY Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire	4.29	—
PRIMARY Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire	1.17	—
PRIMARY Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire	18.41; 19.55; 17.68; 13.45; 18.14; 13.09	—
SECONDARY Healthcare Responsibility (Young Adult Survivors)	2.73; 2.83; 3.1; 3.08; 3.02; 3.07	0.59
SECONDARY Knowledge (Young Adult Survivors)	3.44; 3.9; 4.1; 4.13; 4.4; 4.45	0.03 sig
SECONDARY Self-Management Skills/Self-Efficacy (Young Adult Survivors)	3.4; 3.81; 3.72; 3.92; 3.84; 4.00	0.07
SECONDARY Self-Management Goals (Young Adult Survivors)	3.44; 3.99; 4.10; 4.30; 4.06; 4.30	0.2
SECONDARY Self-Management Beliefs (Young Adult Survivors)	3.59; 3.95; 4.14; 4.06; 4.21; 4.13	0.006 sig
SECONDARY Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale	7.89; 8.28; 8.74; 8.82; 8.56; 8.92	0.86
SECONDARY Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale	3.49; 3.96; 4.08; 4.09; 3.91; 4.36	0.14
SECONDARY Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale	2.39; 3.05; 3.43; 3.63; 3.67; 3.65	0.02 sig
SECONDARY Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale	2.83; 3.25; 3.89; 3.65; 3.92; 3.96	0.29
SECONDARY Health Insurance Self-efficacy (Young Adult Survivors): Scale	2.2; 2.8; 3.06; 3.01; 3.45; 3.55	0.13
SECONDARY Survivorship Care Attitudes (Young Adult Survivors)	4.07; 3.99; 4.35; 4.03; 4.43; 4.25	0.14
SECONDARY Self-efficacy for Managing Emotions (Young Adult Survivors): Scale	3.39; 3.73; 3.85; 3.73; 3.97; 3.86	0.03 sig
SECONDARY Emotional Support (Young Adult Survivors)	4.18; 4.47; 4.36; 4.5; 4.3; 4.5	0.66
SECONDARY Informational Support (Young Adult Survivors)	3.99; 4.35; 4.41; 4.4; 4.23; 4.43	0.15

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04075734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.