Trial Outcomes & Findings for Promoting Resilience in Women With Breast Cancer (NCT NCT06133348)
NCT ID: NCT06133348
Last Updated: 2025-11-10
Results Overview
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
COMPLETED
NA
43 participants
8 months 4 weeks
2025-11-10
Participant Flow
Participant milestones
| Measure |
PRISM Intervention
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Overall Study
STARTED
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43
|
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Overall Study
COMPLETED
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33
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Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
PRISM Intervention
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Overall Study
Death
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3
|
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Overall Study
Lost to Follow-up
|
1
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Overall Study
Physician Decision
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1
|
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Overall Study
Withdrawal by Subject
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5
|
Baseline Characteristics
Promoting Resilience in Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
PRISM Intervention
n=43 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Age, Continuous
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55 Years
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Education
High School, No Degree
|
2 Participants
n=5 Participants
|
|
Education
High School Graduate/GED
|
5 Participants
n=5 Participants
|
|
Education
Some College
|
12 Participants
n=5 Participants
|
|
Education
Associate's Degree
|
8 Participants
n=5 Participants
|
|
Education
Bachelor's Degree
|
5 Participants
n=5 Participants
|
|
Education
Advanced Degree
|
11 Participants
n=5 Participants
|
|
Martial Status
Single, Never Married
|
5 Participants
n=5 Participants
|
|
Martial Status
Married/Partnered
|
18 Participants
n=5 Participants
|
|
Martial Status
Separated/Divorced
|
18 Participants
n=5 Participants
|
|
Martial Status
Widowed
|
2 Participants
n=5 Participants
|
|
Employment Status
Not Employed
|
17 Participants
n=5 Participants
|
|
Employment Status
Part-time
|
6 Participants
n=5 Participants
|
|
Employment Status
Full-time
|
13 Participants
n=5 Participants
|
|
Employment Status
Retired
|
7 Participants
n=5 Participants
|
|
Insurance Coverage
Private
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21 Participants
n=5 Participants
|
|
Insurance Coverage
Medicaid
|
10 Participants
n=5 Participants
|
|
Insurance Coverage
Medicare
|
9 Participants
n=5 Participants
|
|
Insurance Coverage
Medicaid/Medicare Dual Enrollment
|
1 Participants
n=5 Participants
|
|
Insurance Coverage
Veterans Administration/Military
|
1 Participants
n=5 Participants
|
|
Insurance Coverage
Other
|
1 Participants
n=5 Participants
|
|
Rurality
Rural
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2 Participants
n=5 Participants
|
|
Rurality
Urban
|
40 Participants
n=5 Participants
|
|
Rurality
Unknown
|
1 Participants
n=5 Participants
|
|
Area Deprivation Index
Least Deprived
|
31 Participants
n=5 Participants
|
|
Area Deprivation Index
Most Deprived
|
10 Participants
n=5 Participants
|
|
Area Deprivation Index
Unknown
|
2 Participants
n=5 Participants
|
|
Cancer Therapy Type
Neoadjuvant
|
21 Participants
n=5 Participants
|
|
Cancer Therapy Type
Adjuvant
|
11 Participants
n=5 Participants
|
|
Cancer Therapy Type
Metastatic
|
11 Participants
n=5 Participants
|
|
Cancer Stage
Stage I
|
2 Participants
n=5 Participants
|
|
Cancer Stage
Stage II
|
28 Participants
n=5 Participants
|
|
Cancer Stage
Stage III
|
3 Participants
n=5 Participants
|
|
Cancer Stage
Stage IV - New Diagnosis
|
5 Participants
n=5 Participants
|
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Cancer Stage
Stage IV - Recurrent Diagnosis
|
5 Participants
n=5 Participants
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Cancer Subtype
HR+HER2+
|
12 Participants
n=5 Participants
|
|
Cancer Subtype
HR+HER2-
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20 Participants
n=5 Participants
|
|
Cancer Subtype
HR-HER2+
|
2 Participants
n=5 Participants
|
|
Cancer Subtype
HR-HER2-
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7 Participants
n=5 Participants
|
|
Cancer Subtype
HR+HER2 unknown
|
1 Participants
n=5 Participants
|
|
Cancer Subtype
HR-HER2 unknown
|
1 Participants
n=5 Participants
|
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Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 months 4 weeksPopulation: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
Outcome measures
| Measure |
PRISM Intervention
n=43 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Feasibility of PRISM
Completed both pre-post surveys and all 6 sessions
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33 Participants
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Feasibility of PRISM
Didn't complete PRISM
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10 Participants
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SECONDARY outcome
Timeframe: post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Acceptability, appropriateness, and feasibility of the intervention were measured using the Acceptability of Intervention Measure (AIM; scored 1-5), Intervention Appropriateness Measure (IAM; scored 1-5), and Feasibility of Intervention Measure (FIM; scored 1-5). Higher scores indicated better outcomes for each validated survey tool. If means are greater than 4, then the study is considered acceptable, appropriate, and/or feasible.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Acceptable, Appropriate, and Feasible
Acceptability of Intervention Measure (AIM)
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4.5 Scores on a scale
Standard Deviation 0.7
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Acceptable, Appropriate, and Feasible
Intervention Appropriateness Measure (IAM)
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4.5 Scores on a scale
Standard Deviation 0.8
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Acceptable, Appropriate, and Feasible
Feasibility of Intervention Measure (FIM)
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4.6 Scores on a scale
Standard Deviation 0.5
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SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Connor-Davidson Resilience scale (CD-RISC; scored 0-40, higher scores indicate greater resilience)
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Resilience
pre-PRISM
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28.5 Scores on a scale
Standard Deviation 7.0
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Resilience
post-PRISM
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31.8 Scores on a scale
Standard Deviation 5.6
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SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Post-Traumatic Growth Inventory (PTGI; scored 0-105 with factor subscales ranging from 0-10 to 0-35; higher scores indicate more positive transformation). Sub-scores are summed together to receive the overall score.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Overall Post-Traumatic Growth Inventory
pre-PRISM
|
57.4 Scores on a scale
Standard Deviation 28.7
|
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Overall Post-Traumatic Growth Inventory
post-PRISM
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67.8 Scores on a scale
Standard Deviation 28.6
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SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Personal Strength sub-scale is scored from 0-20 with higher scores indicating increased resilience, self-reliance, confidence, humility, etc.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Post-Traumatic Growth Inventory: Personal Strength Sub-scale
pre-PRISM
|
10.9 Scores on a scale
Standard Deviation 6.0
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Post-Traumatic Growth Inventory: Personal Strength Sub-scale
post-PRISM
|
13.2 Scores on a scale
Standard Deviation 6.1
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SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory New Possibilities sub-scale is scored from 0-25 with higher scores indicating an increase in new interests, perspectives, more adaptability and openness to new opportunities.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Post-Traumatic Growth Inventory: New Possibilities Sub-scale
pre-PRISM
|
11 Scores on a scale
Standard Deviation 6.9
|
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Post-Traumatic Growth Inventory: New Possibilities Sub-scale
post-PRISM
|
14.5 Scores on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Improved Relationship sub-scale is scored from 0-35 with higher scores indicating an increased sense of belonging, emotional vulnerability, empathy, more supportive, and have an increased ability to form stronger bonds with others.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Post-Traumatic Growth Inventory: Improved Relationships Sub-scale
pre-PRISM
|
20 Scores on a scale
Standard Deviation 9.9
|
|
Post-Traumatic Growth Inventory: Improved Relationships Sub-scale
post-PRISM
|
22.9 Scores on a scale
Standard Deviation 9.2
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SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Spiritual Growth sub-scale is scored from 0-10 with higher scores indicating deeper and more meaningful beliefs, life philosophies and faith, more awareness, and a clearer purpose in life.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale
post-PRISM
|
6.7 Scores on a scale
Standard Deviation 3.7
|
|
Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale
pre-PRISM
|
6 Scores on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure.
Post-Traumatic Growth Inventory (PTGI; scored 0-105; higher scores indicate more positive transformation). The Post-Traumatic Growth Inventory Appreciation for Life sub-scale is scored from 0-15 with higher scores indicating increased gratitude, appreciation for the positive things in life, and clearer sense of priorities.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale
pre-PRISM
|
9.5 Scores on a scale
Standard Deviation 4.8
|
|
Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale
post-PRISM
|
10.5 Scores on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with each factor scored 0-16, higher scores indicate greater spiritual well-being). The overall score is a summation of each sub-score.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Functional Assessment of Chronic Illness Therapy Spiritual Well-Being
pre-PRISM
|
37.1 Scores on a scale
Standard Deviation 8.2
|
|
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being
post-PRISM
|
40.5 Scores on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with higher scores indicate greater spiritual well-being). The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Meaning sub-scale is scored from 0-16 with one question reverse coded. Item scores for the sub-scale are summed, multiplied by 4, and divided by the number of items answered by the participant. A higher score indicates a greater sense of a meaningful life.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score
pre-PRISM
|
13.2 Scores on a scale
Standard Deviation 3
|
|
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score
post-PRISM
|
14.5 Scores on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with higher scores indicate greater spiritual well-being). The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Peace sub-scale is scored from 0-16 with one question reverse coded. Item scores for the sub-scale are summed, multiplied by 4, and divided by the number of items answered by the participant. A higher score indicates a greater sense of inner peace or harmony.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
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Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score
pre-PRISM
|
11 Scores on a scale
Standard Deviation 3.4
|
|
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score
post-PRISM
|
12.5 Scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being tool (FACIT-Sp; scored 0-48 with higher scores indicate greater spiritual well-being). The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Faith sub-scale is scored from 0-16. Item scores for the sub-scale are summed, multiplied by 4, and divided by the number of items answered by the participant. A higher score indicates a greater sense of faith and spiritual beliefs.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score
pre-PRISM
|
12.9 Scores on a scale
Standard Deviation 3.7
|
|
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score
post-PRISM
|
13.6 Scores on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Patient Activation Measure (PAM; scored 0-100, higher scores indicate greater activation)
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
|
Patient Activation Measure
pre-PRISM
|
41.3 Scores on a scale
Standard Deviation 5.4
|
|
Patient Activation Measure
post-PRISM
|
41.9 Scores on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Fear of Cancer Recurrence Inventory (FCRI-SF; scored 0-36, higher scores indicate greater fear of cancer recurrence)
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Fear of Cancer Recurrence Inventory
pre-PRISM
|
17.9 Scores on a scale
Standard Deviation 7.1
|
|
Fear of Cancer Recurrence Inventory
post-PRISM
|
15.4 Scores on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Patient Health Questionnaire (PHQ-8; scored 0-24, higher scores indicate worse depressive symptoms)
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Patient Health Questionnaire
pre-PRISM
|
6.4 Scores on a scale
Standard Deviation 5.4
|
|
Patient Health Questionnaire
post-PRISM
|
5.2 Scores on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
General Anxiety Disorder Anxiety Scale (GAD-7; scored 0-21, higher scores indicate worse anxiety)
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
General Anxiety Disorder Anxiety Scale
pre-PRISM
|
6.2 Scores on a scale
Standard Deviation 5.8
|
|
General Anxiety Disorder Anxiety Scale
post-PRISM
|
5.1 Scores on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Patient-Reported Outcomes Measurement Information System Global Health - Physical Health (PROMIS-Global; physical health scored 4-20 with T-scores ranging from 16.2-67.7 and standard errors ranging from 4.8-5.9). A T-score of 50 represents the mean for the general population with a standard deviation of 10. A higher T-score indicates better physical health. A lower T-score would indicate a decrease in physical health.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
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Patient-Reported Outcomes Measurement Information System Global Health: Physical Health
pre-PRISM
|
44.7 T-score
Standard Deviation 9.1
|
|
Patient-Reported Outcomes Measurement Information System Global Health: Physical Health
post-PRISM
|
44 T-score
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
Patient-Reported Outcomes Measurement Information System Global Health - Mental Health (PROMIS-Global; mental health scored 4-20 with T-scores ranging from 21.2-67.6 and standard errors ranging from 4.6-5.3). A T-score of 50 represents the mean for the general population with a standard deviation of 10. A higher T-score indicates better mental health. A lower T-score would indicate a decrease in mental health.
Outcome measures
| Measure |
PRISM Intervention
n=33 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
|
Patient-Reported Outcomes Measurement Information System Global Health: Mental Health
pre-PRISM
|
45.7 T-score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System Global Health: Mental Health
post-PRISM
|
46.5 T-score
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
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|---|---|
|
Cholesterol
pre-PRISM
|
184.8 mg/dL
Standard Deviation 33.3
|
|
Cholesterol
post-PRISM
|
196.9 mg/dL
Standard Deviation 53.4
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Triglycerides
pre-PRISM
|
123.4 mg/dL
Standard Deviation 80.4
|
|
Triglycerides
post-PRISM
|
140 mg/dL
Standard Deviation 97.1
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
High Density Lipoprotein
pre-PRISM
|
52.7 mg/dL
Standard Deviation 14.5
|
|
High Density Lipoprotein
post-PRISM
|
56.3 mg/dL
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
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Low Density Lipoprotein
post-PRISM
|
112.6 mg/dL
Standard Deviation 41.4
|
|
Low Density Lipoprotein
pre-PRISM
|
107.4 mg/dL
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Urea
pre-PRISM
|
14.7 mg/dL
Standard Deviation 4.6
|
|
Urea
post-PRISM
|
13.9 mg/dL
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Albumin
pre-PRISM
|
4.2 g/dL
Standard Deviation 0.3
|
|
Albumin
post-PRISM
|
4.3 g/dL
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Creatinine
post-PRISM
|
1.2 mg/dL
Standard Deviation 0.4
|
|
Creatinine
pre-PRISM
|
1.1 mg/dL
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Serum Cortisol
pre-PRISM
|
7.7 mg/dL
Standard Deviation 4.3
|
|
Serum Cortisol
post-PRISM
|
9.6 mg/dL
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Homocysteine
pre-PRISM
|
8.5 umol/L
Standard Deviation 3.7
|
|
Homocysteine
post-PRISM
|
9.5 umol/L
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
HbA1c
pre-PRISM · Normal (<5.7%)
|
9 Participants
|
|
HbA1c
pre-PRISM · Pre-diabetic (5.7-6.4%)
|
13 Participants
|
|
HbA1c
pre-PRISM · Diabetic (>6.4%)
|
3 Participants
|
|
HbA1c
post-PRISM · Normal (<5.7%)
|
11 Participants
|
|
HbA1c
post-PRISM · Pre-diabetic (5.7-6.4%)
|
9 Participants
|
|
HbA1c
post-PRISM · Diabetic (>6.4%)
|
5 Participants
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
C-Reactive Protein
pre-PRISM · Low Risk (<1 mg/L)
|
2 Participants
|
|
C-Reactive Protein
pre-PRISM · Average Risk (1-3 mg/L)
|
10 Participants
|
|
C-Reactive Protein
pre-PRISM · High Risk (>3 mg/L)
|
13 Participants
|
|
C-Reactive Protein
post-PRISM · Low Risk (<1 mg/L)
|
2 Participants
|
|
C-Reactive Protein
post-PRISM · Average Risk (1-3 mg/L)
|
10 Participants
|
|
C-Reactive Protein
post-PRISM · High Risk (>3 mg/L)
|
13 Participants
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Tumor Necrosis Factor Alpha
pre-PRISM
|
1.4 pg/mL
Standard Deviation 0.6
|
|
Tumor Necrosis Factor Alpha
post-PRISM
|
1.4 pg/mL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Interleukin-6
pre-PRISM
|
1.7 pg/mL
Standard Deviation 1.9
|
|
Interleukin-6
post-PRISM
|
1.9 pg/mL
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
One point was assigned if BMI\>30, systolic (SBP)\>140 mmHg or diastolic blood pressure (DBP)\>90 abstracted from the closest clinical encounter to the baseline visit, high-sensitivity C-reactive protein \>0.41 mg/dL, HgbA1c\>5.4, albumin\<4 gm/dL and/or creatinine clearance \<59 ml/min, total cholesterol \>240 and/or triglycerides \>150 mg/dL. The score range for this measure ranged from 0-9 with higher scores indicating a higher burden of stress or strain on the patient's body that can lead to worse outcomes.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Allostatic Load
post-PRISM
|
3.7 Scores on a scale
Standard Deviation 1.7
|
|
Allostatic Load
pre-PRISM
|
3.9 Scores on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)Population: Biomarkers were only collected on participants with early-stage breast cancer (n=32). Of the 32 participants, 25 completed both surveys, biomarker collection timepoints, and all PRISM sessions.
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Outcome measures
| Measure |
PRISM Intervention
n=25 Participants
This single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the PRISM intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the PRISM intervention.
|
|---|---|
|
Nail Cortisol
pre-PRISM · Low (<=0.125)
|
14 Participants
|
|
Nail Cortisol
pre-PRISM · Moderate (0.126-0.724)
|
3 Participants
|
|
Nail Cortisol
pre-PRISM · High (>=0.725)
|
6 Participants
|
|
Nail Cortisol
pre-PRISM · unknown
|
2 Participants
|
|
Nail Cortisol
post-PRISM · Low (<=0.125)
|
4 Participants
|
|
Nail Cortisol
post-PRISM · Moderate (0.126-0.724)
|
10 Participants
|
|
Nail Cortisol
post-PRISM · High (>=0.725)
|
4 Participants
|
|
Nail Cortisol
post-PRISM · unknown
|
7 Participants
|
Adverse Events
PRISM Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gabrielle Rocque, MD, MSPH
University of Alabama at Birmingham Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place