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Completed

NCT Number: NCT04075734

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

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).

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Key information

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, 08901, United States

About this study

PRIMARY OBJECTIVES:

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

II. Assess preliminary efficacy of the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline

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

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

    Time frame: Time 3 at about 5 months since Baseline.

    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%.

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

    Time frame: Time 2, about 2 months since baseline.

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

  4. Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean

    Time frame: Time 2, about 2 months since baseline.

    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.

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

    Time frame: Time 2, about 2 months since baseline.

    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.

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

    Time frame: Time 2, about 2 months since baseline.

    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.

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

    Time frame: Time 2, about 2 months since baseline.

    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.

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

    Time frame: Time 2, about 2 months since baseline

    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.

Secondary outcomes

  1. Healthcare Responsibility (Young Adult Survivors)

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

    The Readiness for Transition Questionnaire - Survivor Version (RTQ) assesses the degree to which survivors are responsible for 10 healthcare behaviors, including knowing their survivorship care plan, scheduling annual visits, scheduling specialist appointments, taking and filling medications (if prescribed), explaining medical history to others, knowing insurance coverage, attending appointments, communicating with providers, and calling providers, on a 4-point scale, with higher scores indicating higher levels of responsibility. The RTQ yields a total mean score for responsibility. It also has one item evaluating "overall readiness to assume complete responsibility for healthcare" with response options of Not at all ready, somewhat ready, mostly ready, or completely ready. The sample mean for the Total Responsibility score and overall readiness item will be calculated (range 1-4)

  2. Knowledge (Young Adult Survivors)

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

    The knowledge subscale from the Transition Readiness Inventory (TRI) measures knowledge of survivorship care using a 5-point scale, with higher scores indicating greater knowledge. A mean score will be calculated (range 1-5).

  3. Self-Management Skills/Self-Efficacy (Young Adult Survivors)

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

    The Skills/Self-Efficacy sub-scale from the Transition Readiness Inventory (TRI) measures self-management skills and self-efficacy for survivorship care using a 5-point scale, with higher scores indicating greater skills/efficacy. A mean score will be calculated (range 1-5).

  4. Self-Management Goals (Young Adult Survivors)

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

    The Goals subscale from the Transition Readiness Inventory (TRI) measures self-management goals for survivorship care using a 5-point scale, with higher scores indicating greater goals. A mean score will be calculated (range 1-5).

  5. Self-Management Beliefs (Young Adult Survivors)

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

    The Beliefs/Expectations sub-scale from the Transition Readiness Inventory (TRI) measures self-management beliefs for survivorship care using a 5-point scale, with higher scores indicating more positive beliefs. A mean score will be calculated (range 1-5).

  6. Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale

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

    This single item measures confidence in communicating with a physician about health concerns using a 10-point scale, with higher scores indicating greater confidence. Range is from 1-10.

  7. Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale

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

    This scale measures confidence in communicating with family about healthcare concerns using a 5-point scale, with higher scores indicating greater confidence. A mean score is calculated (range from 1-5).

  8. Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale

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

    This scale consists of three items measuring confidence in managing late effects using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).

  9. Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale

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

    This scale consists of three items measuring confidence in survivorship care planning using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).

  10. Health Insurance Self-efficacy (Young Adult Survivors): Scale

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

    This scale consists of seven items measuring confidence in managing health insurance using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).

  11. Survivorship Care Attitudes (Young Adult Survivors)

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

    This scale consists of four items measuring attitudes toward survivorship care using a 5-point scale, with higher scores indicating more positive attitudes. A mean score is calculated (range 1-5).

  12. Self-efficacy for Managing Emotions (Young Adult Survivors): Scale

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

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Emotions-Short Form is an 8-item measure of confidence in managing emotions. A mean score will be calculated (range 1-5). Higher scores indicate higher confidence in managing emotions.

  13. Emotional Support (Young Adult Survivors)

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

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support-Short Form is a 4-item measure of perceived emotional support. A mean score will be calculated (range 1-5), with higher scores indicative of having better perceived emotional support.

  14. Informational Support (Young Adult Survivors)

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

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support-Short Form is a 4-item measure of perceived availability of helpful information or advice. A mean score will be calculated (range 1-5), with higher scores indicating higher perceived informational support.

Other outcomes

  1. Healthcare Utilization (Young Adult Survivors)

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

    As an exploratory outcome, participants will report on receipt of the following healthcare (if applicable): Survivorship Care Plan, annual survivorship visit, echocardiogram within last 5 years, mammogram ever (females only), skin cancer screening ever, primary care visit in last 2 years, dental visit in the last year, annual flu vaccine up-to-date, and human papillomavirus (HPV) vaccine ever. Each item will be treated individually. The number of survivors reporting receipt of each healthcare service will be counted. "Yes" indicates receipt within time frame indicated for the outcome; "No" indicates either not received or not due per self-report.

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
2019
Primary completion
2020
Study completion
2021
First posted
Sep 3, 2019
Registry last updated
May 31, 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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