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.

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

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.

Managing Your Health: Self-Management + Peer Mentoring

Katie Devine, PhD

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).

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.

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

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.

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

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

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.

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.

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.

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.

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.

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)

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).

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).

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).

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).

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.

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).

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).

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).

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).

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).

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.

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.

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.

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Assistant Professor of Medicine

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.

Managing Your Health: Self-Management + Peer Mentoring: 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.

Intervention

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.

Usual Care

Peer Mentors were recruited and matched 1:1 with each participant randomized to RCT Intervention to facilitate engagement with the online modules and offer specialized support.

Mentors

RCT Intervention

RCT Usual Care

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Katie Devine

Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.

Randomized Control Trial Participants-Young Adult Survivors

All potentially eligible participants identified by the New Jersey State Cancer Registry (NJSCR) and approached at the local Long-Term Information Treatment Evaluation (LITE) program by study staff.

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

Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.

Young Adult Survivors who enrolled on study, i.e., consented and completed baseline.

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

On-line self-management educational modules

Weekly calls with peer mentor

Data available and reported only for participants who were assigned to this group and completed the tested intervention, i.e., n=22. Total of three participants assigned to this group, withdrew from the study, without completing the tested intervention.

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

a. Satisfaction w/ Program overall [Scale 1-5]

b. Satisfaction w/ Content of online modules [Scale 1-5]

c. Satisfaction w/ Discussions with peer mentor [Scale 1-5]

d. Satisfaction w/ Frequency of calls with peer mentor [Scale 1-3; 2="Just right"]

e. Satisfaction w/ Duration of program [Scale 1-5; 3= "Just right"

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

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

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

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

Bond

Goal

Task

Peer Mentors were recruited and matched 1:1 with each participant randomized to Intervention to facilitate engagement with the online modules and offer specialized support.

Peer mentors and young adult survivors in RCT Intervention group who completed the tested intervention (i.e., n=22). Please note, while total number of mentors on study was n=10, total reports by mentors for this measure was n=22 (some mentors were assigned to mentor more than one young adult survivor assigned to RCT intervention group.)

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

Baseline RTQ Total

Time 2 RTQ Total

Time 3 RTQ Total

Time 4 RTQ Total

Baseline RTQ Overall readiness

Time 2 RTQ Overall readiness

Time 3 RTQ Overall readiness

Time 4 RTQ Overall readiness

Healthcare Responsibility (Young Adult Survivors)

Baseline

Time 2

Time 3

Knowledge (Young Adult Survivors)

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

Self-Management Goals (Young Adult Survivors)

Self-Management Beliefs (Young Adult Survivors)

Time 4

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

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

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

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

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

Survivorship Care Attitudes (Young Adult Survivors)

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

Emotional Support (Young Adult Survivors)

Informational Support (Young Adult Survivors)

Survivorship Care Plan-Baseline : yes

Survivorship Care Plan-Time 3 : yes

Survivorship Care Plan-Time 4 : yes

Annual survivorship visit-Baseline: yes

Annual survivorship visit-Time 3: yes

Annual survivorship visit-Time 4: yes

Echocardiogram-Baseline: yes

Echocardiogram-Time 3: yes

Echocardiogram-Time 4: yes

Mammogram-Baseline: yes

Mammogram-Time 3: yes

Mammogram-Time 4: yes

Skin cancer screening-Baseline: yes

Skin cancer screening-Time 3: yes

Skin cancer screening-Time 4: yes

Primary care visit-Baseline: yes

Primary care visit-Time 3: yes

Primary care visit-Time 4: yes

Dental visit-Baseline: yes

Dental visit-Time 3: yes

Dental visit-Time 4: yes

Annual flu vaccine-Baseline

Annual flu vaccine-Time 3

Annual flu vaccine-Time 4

Human papillomavirus (HPV) vaccine-Baseline: yes

Human papillomavirus (HPV) vaccine-Time 3: yes

Human papillomavirus (HPV) vaccine-Time4: yes

Mammogram measure was only administered to females so the sample size for those analyses represent the number of females in each arm.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial