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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-02098 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro20150001955 | |||
| 131507 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-management + peer mentoring | Experimental | Participants complete the self-management + peer mentoring intervention comprising 5 online educational modules and 6 videoconference or phone calls with the peer mentor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Complete interview |
| |
| 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). |
| 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. |
| 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. |
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Inclusion Criteria:
PEER MENTOR ELIGIBILITY:
PATIENT ELIGIBILITY:
Exclusion Criteria:
PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare
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| Name | Affiliation | Role |
|---|---|---|
| Katie Devine | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Intervention Participants | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| FG001 | Group Intervention Mentors | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Group Intervention Participants: all completed baseline survey. Group Intervention Mentors: all completed Mentor training.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Intervention Participants | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| BG001 | Group Intervention Mentors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%). | Group Intervention Participants: the total number of potential participants identified by the Cancer Registry, whose contact information was provided to our study team for recruitment. Group Intervention Mentors-identified and recommended by the local survivorship clinic physicians and clinical staff. | Posted | Count of Participants | Participants | 6 weeks |
|
For the study duration, i.e., ~6 weeks for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Intervention Participants | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katie Devine | Rutgers Cancer Inst. of NJ | 7322357549 | katie.devine@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2017 | Apr 18, 2019 | Prot_SAP_000.pdf |
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| Telephone-Based Intervention |
| Behavioral |
Complete the self management + peer mentoring intervention with videoconferencing |
|
| 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 |
one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group Intervention Mentors | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
|
|
| Primary | 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). |
| Satisfaction with intervention, administered to all Participants, i.e., Group Intervention Participants, n=15. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks (post-intervention) |
|
|
|
| Primary | 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. | Mentors completed satisfaction with training questionnaire after completion of the Mentor Training and prior to being matched with a participant (mentee). | Posted | Mean | Standard Deviation | score on a scale | Time of enrollment, after completing mentor training. |
|
|
|
| Secondary | 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. | All participants who completed baseline assessment, intervention, and follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | Participants who completed baseline, intervention, and follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | We had missing data for one participant, therefore total number of participants analyzed is 14. | Posted | Mean | Standard Deviation | T-score | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T-score | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | Participants | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | Participants | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | Participants | Posted | Mean | Standard Deviation | score on a scale | Baseline to up to 6 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Group Intervention Mentors | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Ineligible |
|
| Declined participation/No time |
|
| Unable to reach |
|
| Ineligible |
|
| Declined participation/No time |
|
| Unable to reach |
|
| Ineligible |
|
| Declined participation/No time |
|
| Unable to reach |
|
|
| Frequency of calls [Range 1-3; 2="Just right"] |
|
| Program duration [Range 1-5;3="Just right"] |
|
| Amount of ed materials read [Range 1-5] |
|
| Internet Utility Total Score [Range 1-5] |
|
| Impact Questionnaire Total Score [Range 1-5] |
|
| Adherence Questionnaire Total [Range 1-3] |
|
|
| RTQ-Overall Readiness post- |
|
| t-test, 2 sided |
df=14 |
| <.01 |
| Mean Difference (Final Values) |
| 0.67 |
| 2-Sided |
| 95 |
| 0.27 |
| 1.07 |
| Superiority |
| Title | Measurements |
|---|---|
|
| TRI Knowledge post- |
|
| TRI Skills/Self-Efficacy pre- |
|
| TRI Skills/Self-Efficacy post- |
|
| TRI Beliefs/Expectations pre- |
|
| TRI Beliefs/Expectations post- |
|
| TRI Goals/Motivation pre- |
|
| TRI Goals/Motivation post- |
|
| TRI Relationship/Communication pre- |
|
| TRI Relationship/Communication post- |
|
| TRI Psychosocial/Emotional pre- |
|
| TRI Psychosocial/Emotional post- |
|
df=14 |
| <.01 |
| Mean Difference (Final Values) |
| 0.49 |
| 2-Sided |
| 95 |
| 0.26 |
| 0.73 |
| Superiority |
| TRI Skills/Self-Efficacy Score | t-test, 2 sided | df=14 | 0.053 | Mean Difference (Final Values) | 0.30 | 2-Sided | 95 | -0.0044 | 0.60 | Superiority |
| TRI Beliefs/Expectations score | t-test, 2 sided | df=14 | 0.03 | Mean Difference (Final Values) | 0.13 | 2-Sided | 95 | 0.02 | 0.24 | Superiority |
| TRI Goals/Motivation score | t-test, 2 sided | df=14 | <.01 | Mean Difference (Final Values) | 0.40 | 2-Sided | 95 | 0.11 | 0.69 | Superiority |
| Relationship/Communication Score | t-test, 2 sided | df=14 | 0.61 | Mean Difference (Final Values) | 0.05 | 2-Sided | 95 | -0.16 | 0.26 | Superiority |
| TRI Psychosocial/Emotional Score | t-test, 2 sided | df=14 | 0.65 | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | -0.37 | 0.57 | Superiority |
| Title | Measurements |
|---|---|
|
| Personal Growth post- |
|
| Memory pre- |
|
| Memory post- |
|
df = 14 |
| .40 |
| Mean Difference (Final Values) |
| -0.13 |
| 2-Sided |
| 95 |
| -0.46 |
| 0.20 |
| Superiority |
| Memory Subscale | t-test, 2 sided | df = 14 | .29 | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | -0.09 | 0.29 | Superiority |