Peer Mentoring in Promoting Follow-up Care Self-Management in Younger Childhood Cancer Survivors

NCT02699996 | Completed Results

• 4 other identifiers: Pro20150001955NCI-2015-02098131507P30CA072720
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor

Keywords

Cancer Survivor; Young Adult; Peer Mentor

Outcome Measures

Primary Outcomes (3)

• Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out.

  Descriptive analyses will be used to evaluate expected enrollment (\> 50%), retention (\> 80%), and completion of intervention sessions (\> 75%).

  6 weeks

• 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).

  1. General Satisfaction: Average of each item reported separately. 1: Program; 2: Online educational materials; 3: Discussion with mentor; 4: Frequency of calls; 5: Program duration; 6: Material read. Items 1, 2, 3, \& 6 are rated on a 1 "not at all" to 5 "very" scale (higher=higher satisfaction). Item 4 uses a 1 "not frequent enough" to 3 "too frequent" scale. Item 5 uses a 1 "way too short" to 5 "way too long" scale. 2. 12-items adapted from Internet Intervention Utility Questionnaire; measures perceived usefulness on 1 "not at all" to 5 "very" scale, higher=higher usefulness. Average total score reported. 3. 16-item Impact Questionnaire measures perceived effectiveness in improving targeted skills using 1 "not at all" to 5 "very" scale (higher=greater perceived effectiveness). Average total score reported. 4. 6-item Adherence Questionnaire measures barriers to engagement using 1 "not a problem" to 3 "major problem" scale. (higher=bigger barrier). Average total score reported.

  6 weeks (post-intervention)

• Mentor Training Satisfaction

  Mentor 6-item Training Satisfaction measured on a scale from 1 "strongly disagree" to 4 "strongly agree" (higher score=high satisfaction). Administered to Group Intervention Mentors only. Total average score is reported.

  Time of enrollment, after completing mentor training.

Secondary Outcomes (8)

• Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version

  Baseline to up to 6 weeks

• Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2).

  Baseline to up to 6 weeks

• Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b).

  Baseline to up to 6 weeks

• Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)

  Baseline to up to 6 weeks

• Cancer Related Worry Scale

  Baseline to up to 6 weeks

Study Arms (1)

self-management + peer mentoring

EXPERIMENTAL

Participants complete the self-management + peer mentoring intervention comprising 5 online educational modules and 6 videoconference or phone calls with the peer mentor.

Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Interventions

Questionnaire Administration OTHER

Complete interview

self-management + peer mentoring

Telephone-Based Intervention BEHAVIORAL

Complete the self management + peer mentoring intervention with videoconferencing

self-management + peer mentoring

Eligibility Criteria

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

You may qualify if:

• 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)

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, 08903, United States

Location

Results Point of Contact

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

katie.devine@rutgers.edu

7322357549

Study Officials

• Katie Devine

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 7, 2016
• Study Start: January 14, 2016
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: October 19, 2022
• Results First Posted: August 10, 2020

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)