- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075734
Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors
Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers Cancer Institute of New Jersey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks.
|
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. |
No Intervention: Usual Care
Participants are not receiving the tested intervention.
They continue to receive standard or routine psychosocial or transition care available to them as part of the normal practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline
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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%.
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Time 3 at about 5 months since Baseline.
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Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage
Time Frame: Time 2, about 2 months since baseline.
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Mean percent completed per task: (a) On-line self-management educational modules and (b) Weekly calls with peer mentor.
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Time 2, about 2 months since baseline.
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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.
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Time 2, about 2 months since baseline.
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Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
Time Frame: Time 2, about 2 months since baseline.
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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.
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Time 2, about 2 months since baseline.
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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.
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Time 2, about 2 months since baseline.
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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.
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Time 2, about 2 months since baseline.
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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.
|
Time 2, about 2 months since baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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Knowledge (Young Adult Survivors)
Time Frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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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)
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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Self-Management Goals (Young Adult Survivors)
Time Frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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Self-Management Beliefs (Young Adult Survivors)
Time Frame: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
|
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).
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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.
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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).
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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).
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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).
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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).
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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).
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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).
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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)
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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.
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)
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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).
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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.
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Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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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).
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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.
|
Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Katie Devine, PhD, Rutgers Cancer Inst. of NJ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20150001955
- R21CA222936 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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