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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer Survivor

Intervention / Treatment
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* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-management + peer mentoring<br>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<br>* Complete interview<br>Behavioral: Telephone-Based Intervention<br>* Complete the self management + peer mentoring intervention with videoconferencing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivor, Young Adult, Peer Mentor