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

NCT04075734 | Completed Results DMC

• 2 other identifiers: 20150001955R21CA222936
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Childhood Cancer Survivors

Outcome Measures

Primary Outcomes (8)

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

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

  Baseline

• Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up

  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%.

  Time 3 at about 5 months since Baseline.

• Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage

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

  Time 2, about 2 months since baseline.

• Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean

  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.

  Time 2, about 2 months since baseline.

• Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire

  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.

  Time 2, about 2 months since baseline.

• Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire

  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.

  Time 2, about 2 months since baseline.

• Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire

  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.

  Time 2, about 2 months since baseline.

• Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire

  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.

  Time 2, about 2 months since baseline

Secondary Outcomes (14)

• Healthcare Responsibility (Young Adult Survivors)

  Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

• Knowledge (Young Adult Survivors)

  Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

• Self-Management Skills/Self-Efficacy (Young Adult Survivors)

  Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

• Self-Management Goals (Young Adult Survivors)

  Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

• Self-Management Beliefs (Young Adult Survivors)

  Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

Other Outcomes (1)

• Healthcare Utilization (Young Adult Survivors)

  Baseline, Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks.

Behavioral: Managing Your Health: Self-Management + Peer Mentoring

Usual Care

NO INTERVENTION

Participants are not receiving the tested intervention. They continue to receive standard or routine psychosocial or transition care available to them as part of the normal practice

Interventions

Managing Your Health: Self-Management + Peer Mentoring BEHAVIORAL

The online educational component consists of 5 self-management educational modules: (1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy. Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call.

Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Results Point of Contact

• Title: Dr. Katie Devine
• Organization: Rutgers Cancer Institute of NJ

katie.devine@rutgers.edu

7322357549

Study Officials

• Katie Devine, PhD

  Rutgers Cancer Inst. of NJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2019
• Primary Completion: October 12, 2020
• Study Completion: May 26, 2021
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)