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

Cancer Survivor Clinical Trial

Official title:

Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699996
• Other study ID #: Pro20150001955
• Secondary ID: NCI-2015-02098Pr
• Status: Completed
• Phase: N/A
• Start date: January 14, 2016
• Est. completion date: May 7, 2018

Study information

• Verified date: October 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

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

II. Assess preliminary outcomes of the peer mentoring program.

OUTLINE:

All Participants will be asked to complete online self-management educational modules and 6 weekly peer mentor calls to facilitate engagement with the online modules and offer specialized support. We will also recruit and train peer Mentors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare

Related Conditions & MeSH terms

• Cancer Survivor

Intervention

Other:
• Questionnaire Administration
Complete interview

Behavioral:
• Telephone-Based Intervention
Complete the self management + peer mentoring intervention with videoconferencing

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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).	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.; 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.; 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.; 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)
Primary	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	Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version	Respondents rate how responsible they are for various healthcare tasks on a 4-point scale, where 1= "not responsible at all", and 4= "almost always responsible." The Adolescent Responsibility Scale is calculated by averaging responses across all 10 items (RTQ-Survivor). A single item assessing "overall readiness to assume complete responsibility for health care" on the same 4-point scale is analyzed separately.	Baseline to up to 6 weeks
Secondary	Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2).	The Transition Readiness Inventory (TRI) yields six sub-scale scores: Knowledge, Skills/Self-Efficacy, Beliefs/Expectations, Goals/Motivation, Relationship/Communication, and Psychosocial/Emotional. Total average score is reported across all sub-scales (TRI-total), as well as each sub-scale total score. Scores are averaged across items on a 5-point scale from 1 "not at all" to 5 "extremely" or "always," with higher scores indicating better functioning.	Baseline to up to 6 weeks
Secondary	Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b).	Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.	Baseline to up to 6 weeks
Secondary	Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)	Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.	Baseline to up to 6 weeks
Secondary	Cancer Related Worry Scale	This 4-item scale is measuring cancer-related worries (i.e., recurrence of cancer, future diagnostic tests, cancer coming back, other type of cancer). A total score is calculated by averaging across items on a 5-point scale (from 1="Strongly disagree" to 5="Strongly agree"), with higher scores indicating greater worry. Total average score is reported.	Baseline to up to 6 weeks
Secondary	Short Grit Scale	Perseverance is measured via the The Short Grit Scale, an 8-item measure of perseverance for long-term goals. A total scale score is calculated by averaging across all items, on a 5-point scale (from 1 "not at all like me" to 5 "very much like me"), with higher scores indicating greater perseverance.	Baseline to up to 6 weeks
Secondary	Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale	The three subscales measure perceptions of cancer impact on Body Health (8 items), Personal Growth (5 items), and Memory Problems (4 items). Sub-scales are scored by averaging across items using a 5-point scale (where 1="not at all", and 5="very much"), with higher scores indicating greater impact.	Baseline to up to 6 weeks
Secondary	Barriers to Follow-up Care & Adherence	Barriers to follow-up care & adherence evaluated by insurance status, current provider, and other barriers to care using 6 items from the Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS). Participants report on appointments, cancer screening, and other adherence markers on a 5-point scale (from 1="Strongly disagree" to 5="Strongly agree"), where higher score indicates grater barrier. Total average score is reported.	Up to 6 weeks