Peer Mentoring in Promoting Follow-up Care Self-Management in Younger Childhood Cancer Survivors
Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT02699996
Collaborator
National Cancer Institute (NCI) (NIH)
31
1
1
27.7
1.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
-
Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.
-
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Actual Study Start Date
:
Jan 14, 2016
Actual Primary Completion Date
:
May 7, 2018
Actual Study Completion Date
:
May 7, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: self-management + peer mentoring Participants complete the self-management + peer mentoring intervention comprising 5 online educational modules and 6 videoconference or phone calls with the peer mentor. |
Other: Questionnaire Administration
Complete interview
Behavioral: Telephone-Based Intervention
Complete the self management + peer mentoring intervention with videoconferencing
|
Outcome Measures
Primary Outcome Measures
- Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. [6 weeks]
Descriptive analyses will be used to evaluate expected enrollment (> 50%), retention (> 80%), and completion of intervention sessions (> 75%).
- 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)]
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.
- Mentor Training Satisfaction [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 Outcome Measures
- Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version [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.
- Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). [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.
- Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b). [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.
- Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) [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.
- Cancer Related Worry Scale [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.
- Short Grit Scale [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.
- Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale [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.
- Barriers to Follow-up Care & Adherence [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Katie Devine, Rutgers Cancer Institute of New Jersey
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Katie Devine, PhD, MPH,
Assistant Professor of Medicine,
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT02699996
Other Study ID Numbers:
- Pro20150001955
- NCI-2015-02098
- Pro20150001955
- 131507
- P30CA072720
First Posted:
Mar 7, 2016
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Katie Devine, PhD, MPH,
Assistant Professor of Medicine,
Rutgers, The State University of New Jersey
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group Intervention Participants | Group Intervention Mentors |
|---|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Period Title: Overall Study | ||
| STARTED | 20 | 11 |
| COMPLETED | 15 | 9 |
| NOT COMPLETED | 5 | 2 |
Baseline Characteristics
| Arm/Group Title | Group Intervention Participants | Group Intervention Mentors | Total |
|---|---|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | Total of all reporting groups |
| Overall Participants | 20 | 11 | 31 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
100%
|
11
100%
|
31
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
45%
|
5
45.5%
|
14
45.2%
|
| Male |
11
55%
|
6
54.5%
|
17
54.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
9.1%
|
1
3.2%
|
| Native Hawaiian or Other Pacific Islander |
1
5%
|
0
0%
|
1
3.2%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
17
85%
|
10
90.9%
|
27
87.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
10%
|
0
0%
|
2
6.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
20
100%
|
11
100%
|
31
100%
|
Outcome Measures
| Title | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. |
|---|---|
| Description | Descriptive analyses will be used to evaluate expected enrollment (> 50%), retention (> 80%), and completion of intervention sessions (> 75%). |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group Intervention Participants | Group Intervention Mentors |
|---|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 36 | 11 |
| Eligible on study |
20
100%
|
11
100%
|
| Ineligible |
8
40%
|
0
0%
|
| Declined participation/No time |
1
5%
|
0
0%
|
| Unable to reach |
7
35%
|
0
0%
|
| Eligible on study |
0
0%
|
0
0%
|
| Ineligible |
0
0%
|
0
0%
|
| Declined participation/No time |
1
5%
|
2
18.2%
|
| Unable to reach |
4
20%
|
0
0%
|
| Eligible on study |
15
75%
|
9
81.8%
|
| Ineligible |
0
0%
|
0
0%
|
| Declined participation/No time |
1
5%
|
2
18.2%
|
| Unable to reach |
4
20%
|
0
0%
|
| Eligible on study |
15
75%
|
9
81.8%
|
| Ineligible |
0
0%
|
0
0%
|
| Declined participation/No time |
0
0%
|
0
0%
|
| Unable to reach |
0
0%
|
0
0%
|
| Title | 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). |
|---|---|
| Description | 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. |
| Time Frame | 6 weeks (post-intervention) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Satisfaction with intervention, administered to all Participants, i.e., Group Intervention Participants, n=15. |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| Satisfaction w/Program [Range 1-5] |
4.20
(0.86)
|
| Satisfaction w/Online materials [Range 1-5] |
3.80
(1.01)
|
| Satisfaction w/Discussions [Range 1-5] |
4.60
(0.63)
|
| Frequency of calls [Range 1-3; 2="Just right"] |
2.0
(0.39)
|
| Program duration [Range 1-5;3="Just right"] |
3.07
(0.59)
|
| Amount of ed materials read [Range 1-5] |
3.80
(1.01)
|
| Internet Utility Total Score [Range 1-5] |
3.96
(0.69)
|
| Impact Questionnaire Total Score [Range 1-5] |
3.81
(0.90)
|
| Adherence Questionnaire Total [Range 1-3] |
1.12
(0.21)
|
| Title | Mentor Training Satisfaction |
|---|---|
| Description | 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 Frame | Time of enrollment, after completing mentor training. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Mentors completed satisfaction with training questionnaire after completion of the Mentor Training and prior to being matched with a participant (mentee). |
| Arm/Group Title | Group Intervention Mentors |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 11 |
| Mean (Standard Deviation) [score on a scale] |
3.92
(0.16)
|
| Title | Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who completed baseline assessment, intervention, and follow-up assessment. |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| RTQ-Survivor Adolescent Responsibility pre- |
3.08
(0.69)
|
| RTQ-Survivor Adolescent Responsibility post- |
3.60
(0.35)
|
| RTQ-Overall Readiness pre- |
2.60
(0.74)
|
| RTQ-Overall Readiness post- |
3.27
(0.70)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | RTQ-Survivor Adolescent Responsibility Score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.01 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.52 | |
| Confidence Interval |
(2-Sided) 95% 0.17 to 0.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | RTQ-Overall Readiness Score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.01 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.67 | |
| Confidence Interval |
(2-Sided) 95% 0.27 to 1.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed baseline, intervention, and follow-up. |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| TRI-total pre- |
4.03
(0.41)
|
| TRI-total post- |
4.27
(0.23)
|
| TRI Knowledge pre- |
4.21
(0.63)
|
| TRI Knowledge post- |
4.70
(0.37)
|
| TRI Skills/Self-Efficacy pre- |
3.97
(0.65)
|
| TRI Skills/Self-Efficacy post- |
4.27
(0.47)
|
| TRI Beliefs/Expectations pre- |
3.93
(0.39)
|
| TRI Beliefs/Expectations post- |
4.06
(0.34)
|
| TRI Goals/Motivation pre- |
4.15
(0.77)
|
| TRI Goals/Motivation post- |
4.55
(0.54)
|
| TRI Relationship/Communication pre- |
4.23
(0.40)
|
| TRI Relationship/Communication post- |
4.28
(0.40)
|
| TRI Psychosocial/Emotional pre- |
3.69
(0.73)
|
| TRI Psychosocial/Emotional post- |
3.79
(0.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | TRI-total Score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% 0.05 to 0.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | TRI Knowledge score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.01 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.49 | |
| Confidence Interval |
(2-Sided) 95% 0.26 to 0.73 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | TRI Skills/Self-Efficacy Score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.053 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.0044 to 0.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | TRI Beliefs/Expectations score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.13 | |
| Confidence Interval |
(2-Sided) 95% 0.02 to 0.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | TRI Goals/Motivation score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.01 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.40 | |
| Confidence Interval |
(2-Sided) 95% 0.11 to 0.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | Relationship/Communication Score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | TRI Psychosocial/Emotional Score | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df=14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b). |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| We had missing data for one participant, therefore total number of participants analyzed is 14. |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 14 |
| Depression pre- |
52.66
(12.15)
|
| Depression post- |
51.02
(9.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .56 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 13 | |
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -1.64 | |
| Confidence Interval |
(2-Sided) 95% -7.62 to 4.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| Anxiety pre- |
59.29
(14.20)
|
| Anxiety post- |
57.55
(7.97)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .42 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.74 | |
| Confidence Interval |
(2-Sided) 95% -6.23 to 2.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cancer Related Worry Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| Cancer Related Worry pre- |
3.72
(1.20)
|
| Cancer Related Worry post- |
3.43
(1.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .26 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to 0.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Short Grit Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| Grit pre- |
3.29
(0.63)
|
| Grit post- |
3.57
(0.58)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .03 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.28 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline to up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| Body Health pre- |
3.60
(1.13)
|
| Body Health post- |
3.80
(0.86)
|
| Personal Growth pre- |
4.39
(0.67)
|
| Personal Growth post- |
4.25
(0.58)
|
| Memory pre- |
3.02
(0.43)
|
| Memory post- |
3.12
(0.56)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | Body Health Subscale | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .20 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.12 to 0.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | Personal Growth Subscale | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .40 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | Memory Subscale | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .29 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.09 to 0.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Barriers to Follow-up Care & Adherence |
|---|---|
| Description | 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. |
| Time Frame | Up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group Intervention Participants |
|---|---|
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. |
| Measure Participants | 15 |
| Barriers pre- |
2.20
(0.47)
|
| Barriers post- |
2.01
(0.59)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Intervention Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .08 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | df = 14 | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | For the study duration, i.e., ~6 weeks for each participant. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Group Intervention Participants | Group Intervention Mentors | ||
| Arm/Group Description | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | ||
All Cause Mortality |
||||
| Group Intervention Participants | Group Intervention Mentors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/11 (0%) | ||
Serious Adverse Events |
||||
| Group Intervention Participants | Group Intervention Mentors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/11 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Group Intervention Participants | Group Intervention Mentors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/11 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Katie Devine |
|---|---|
| Organization | Rutgers Cancer Inst. of NJ |
| Phone | 7322357549 |
| katie.devine@rutgers.edu |
Responsible Party:
Katie Devine, PhD, MPH,
Assistant Professor of Medicine,
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT02699996
Other Study ID Numbers:
- Pro20150001955
- NCI-2015-02098
- Pro20150001955
- 131507
- P30CA072720
First Posted:
Mar 7, 2016
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021