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Completed

NCT Number: NCT02699996

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

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.

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Key information

Conditions

Cancer Survivor

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Complete interview

Telephone-Based Intervention

Behavioral

Complete the self management + peer mentoring intervention with videoconferencing

Primary outcomes

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

    Time frame: 6 weeks

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

  2. 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).

    Time frame: 6 weeks (post-intervention)

    • 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.

  3. Mentor Training Satisfaction

    Time frame: Time of enrollment, after completing mentor training.

    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.

Secondary outcomes

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

    Time frame: Baseline to up to 6 weeks

    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.

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

    Time frame: Baseline to up to 6 weeks

    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.

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

    Time frame: Baseline to up to 6 weeks

    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.

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

    Time frame: Baseline to up to 6 weeks

    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.

  5. Cancer Related Worry Scale

    Time frame: Baseline to up to 6 weeks

    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.

  6. Short Grit Scale

    Time frame: Baseline to up to 6 weeks

    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.

  7. Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale

    Time frame: Baseline to up to 6 weeks

    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.

  8. Barriers to Follow-up Care & Adherence

    Time frame: Up to 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2016
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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