NCT04075734

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

Completed NA Results posted Last updated 31 May 2022

What this trial tests

NA trial testing Managing Your Health: Self-Management + Peer Mentoring in Childhood Cancer Survivors in 60 participants. Completed in 26 May 2021.

Timeline

1 September 2019

Primary endpoint
12 October 2020

26 May 2021

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	1 September 2019
Primary completion	12 October 2020
Estimated completion	26 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Managing Your Health: Self-Management + Peer Mentoring

Conditions studied

• Childhood Cancer Survivors — all drugs for Childhood Cancer Survivors →

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 18 to 29, any sex, with Childhood Cancer Survivors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline Primary · Baseline

Determined by number of eligible patients consented and completing baseline. Hypothesis: \>50% of eligible will consent and complete the baseline.

Group	Value	95% CI
Randomized Control Trial Participants-Young Adult Survivors	50
Randomized Control Trial Participants-Young Adult Survivors	29

Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up Primary · Time 3 at about 5 months since Baseline.

Retention in study (Young Adult Survivors). Determined by the percent of consented patients who are retained in the study and complete Time 3 follow-up. Hypothesis: \>80%.

Group	Value	95% CI
Intervention	22
Usual Care	25

Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage Primary · Time 2, about 2 months since baseline.

Mean percent completed per task: (a) On-line self-management educational modules and (b) Weekly calls with peer mentor.

On-line self-management educational modules

Group	Value	95% CI
Intervention	95.72	58.8 – 100

Weekly calls with peer mentor

Group	Value	95% CI
Intervention	97.72	66.7 – 100

Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean Primary · Time 2, about 2 months since baseline.

Five items assess satisfaction with each aspect of the intervention: a. Overall program satisfaction; b. Content of online modules; c. Discussions with peer mentor; d. Frequency of calls with peer mentor; and e. Duration of program. First 3 items (a, b and c) were evaluated using a 5-point scale, (Minimum 1, Maximum 5) with higher scores indicating greater satisfaction. Item c evaluated on a scale from 1 "not frequent enough" to 3 "too frequent". Item d uses a 1 "way too short" to 5 "way too long" scale. The sample mean will be examined.

a. Satisfaction w/ Program overall [Scale 1-5]

Group	Value	95% CI
Intervention	4.64	± 0.49

b. Satisfaction w/ Content of online modules [Scale 1-5]

Group	Value	95% CI
Intervention	4.41	± 0.59

c. Satisfaction w/ Discussions with peer mentor [Scale 1-5]

Group	Value	95% CI
Intervention	4.64	± 0.49

d. Satisfaction w/ Frequency of calls with peer mentor [Scale 1-3; 2="Just right"]

Group	Value	95% CI
Intervention	2.00	± 0.31

e. Satisfaction w/ Duration of program [Scale 1-5; 3= "Just right"

Group	Value	95% CI
Intervention	2.86	± 0.47

Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire Primary · Time 2, about 2 months since baseline.

The Utility Questionnaire is an 11-item scale that measures perceived ease of use and convenience of the online program using a 5-point scale, (minimum 1, maximum 5) with higher scores indicating greater perceived utility. An overall mean of all items will be calculated.

Group	Value	95% CI
Intervention	4.35	± 0.54

Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire Primary · Time 2, about 2 months since baseline.

The Impact Questionnaire is a 13-item scale that measures perceived effectiveness of the online program using a 5-point scale, (minimum 1, and maximum 5) with higher scores indicating greater perceived effectiveness. An overall mean of all items will be calculated.

Group	Value	95% CI
Intervention	4.29	± 0.48

Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire Primary · Time 2, about 2 months since baseline.

The Adherence Barriers Questionnaire is a 6-item scale that measures perceived barriers to using the online program using a 5-point scale, (minimum 1 and maximum 5) with higher scores indicating greater perceived barriers. An overall mean of all items will be calculated.

Group	Value	95% CI
Intervention	1.17	± 0.24

Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire Primary · Time 2, about 2 months since baseline

Acceptance will be evaluated by young adult survivors' and peer mentors' report on perceived alliance with each other using the Working Alliance Inventory - Short Form Revised (Hatcher \& Gillaspy, 2006), a validated measure of the quality and strength of the relationship. Items are rated on a 5-point scale. The measure yields 3 subscales summary scores that can range from 5 to 20, with higher scores indicating more positive relationships. Sum scores on each sub-scale with be calculated: Bond, Goal, and Task.

Bond

Group	Value	95% CI
Intervention	18.41	± 1.92
Mentors	19.55	± 1.14

Goal

Group	Value	95% CI
Intervention	17.68	± 2.28
Mentors	13.45	± 1.71

Task

Group	Value	95% CI
Intervention	18.14	± 2.01
Mentors	13.09	± 1.66

Healthcare Responsibility (Young Adult Survivors) Secondary · Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

The Readiness for Transition Questionnaire - Survivor Version (RTQ) assesses the degree to which survivors are responsible for 10 healthcare behaviors, including knowing their survivorship care plan, scheduling annual visits, scheduling specialist appointments, taking and filling medications (if prescribed), explaining medical history to others, knowing insurance coverage, attending appointments, communicating with providers, and calling providers, on a 4-point scale, with higher scores indicating higher levels of responsibility. The RTQ yields a total mean score for responsibility. It also ha

Baseline RTQ Total

Group	Value	95% CI
Intervention	2.73	± 0.63
Usual Care	2.83	± 0.54

Time 2 RTQ Total

Group	Value	95% CI
Intervention	3.1	± 0.67
Usual Care	3.08	± 0.49

Time 3 RTQ Total

Group	Value	95% CI
Intervention	3.02	± 0.72
Usual Care	3.07	± 0.64

Time 4 RTQ Total

Group	Value	95% CI
Intervention	3.16	± 0.64
Usual Care	3.23	± 0.63

Baseline RTQ Overall readiness

Group	Value	95% CI
Intervention	2.36	± 0.76
Usual Care	2.8	± 0.96

Time 2 RTQ Overall readiness

Group	Value	95% CI
Intervention	2.64	± 0.85
Usual Care	2.76	± 0.97

Time 3 RTQ Overall readiness

Group	Value	95% CI
Intervention	2.86	± 0.77
Usual Care	2.8	± 0.91

Time 4 RTQ Overall readiness

Group	Value	95% CI
Intervention	3.14	± 0.79
Usual Care	3.04	± 0.95

Knowledge (Young Adult Survivors) Secondary · Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The knowledge subscale from the Transition Readiness Inventory (TRI) measures knowledge of survivorship care using a 5-point scale, with higher scores indicating greater knowledge. A mean score will be calculated (range 1-5).

Baseline

Group	Value	95% CI
Intervention	3.44	± 0.71
Usual Care	3.9	± 0.76

Time 2

Group	Value	95% CI
Intervention	4.1	± 0.67
Usual Care	4.13	± 0.68

Time 3

Group	Value	95% CI
Intervention	4.4	± 0.7
Usual Care	4.45	± 0.77

Self-Management Skills/Self-Efficacy (Young Adult Survivors) Secondary · Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The Skills/Self-Efficacy sub-scale from the Transition Readiness Inventory (TRI) measures self-management skills and self-efficacy for survivorship care using a 5-point scale, with higher scores indicating greater skills/efficacy. A mean score will be calculated (range 1-5).

Baseline

Group	Value	95% CI
Intervention	3.4	± 0.68
Usual Care	3.81	± 0.71

Time 2

Group	Value	95% CI
Intervention	3.72	± 0.78
Usual Care	3.92	± 0.66

Time 3

Group	Value	95% CI
Intervention	3.84	± 0.76
Usual Care	4.00	± 0.77

Self-Management Goals (Young Adult Survivors) Secondary · Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The Goals subscale from the Transition Readiness Inventory (TRI) measures self-management goals for survivorship care using a 5-point scale, with higher scores indicating greater goals. A mean score will be calculated (range 1-5).

Baseline

Group	Value	95% CI
Intervention	3.44	± 0.91
Usual Care	3.99	± 1

Time 2

Group	Value	95% CI
Intervention	4.10	± 0.71
Usual Care	4.30	± 0.72

Time 3

Group	Value	95% CI
Intervention	4.06	± 0.67
Usual Care	4.30	± 0.89

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized feasibility trial of Managing Your Health: a self-management and peer mentoring intervention for young adult survivors of childhood cancer.
   Kwok G, Levonyan-Radloff K, Masterson M, Ohman-Strickland P, et al · · 2025 · cited 1× · PMID 39883539 · DOI 10.1093/jpepsy/jsaf004