Breast Cancer
Conditions
Brief summary
The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.
Detailed description
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.
Interventions
PRISM is a manualized, brief, skills-based intervention targeting four resilience resources; PRISM is delivered by trained intervention staff (called coaches within the PRISM program). Session 1, Stress-Management. Session 2, Goal setting. Session 3, Cognitive Restructuring. Session 4, Meaning-Making. Session 5 (optional), Coming Together. Session 6 (optional) involved advance care planning to discuss.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer
Exclusion criteria
* patients who do not speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of PRISM | 8 months 4 weeks | Feasibility was defined as 70% of participants completing all sessions and pre/post surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Connor-Davidson Resilience scale (CD-RISC; scored 0-40, higher scores indicate greater resilience) |
| Overall Post-Traumatic Growth Inventory | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Post-Traumatic Growth Inventory: Personal Strength Sub-scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Post-Traumatic Growth Inventory: New Possibilities Sub-scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Post-Traumatic Growth Inventory: Improved Relationships Sub-scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Functional Assessment of Chronic Illness Therapy Spiritual Well-Being | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Patient Activation Measure | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Patient Activation Measure (PAM; scored 0-100, higher scores indicate greater activation) |
| C-Reactive Protein | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Fear of Cancer Recurrence Inventory | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Fear of Cancer Recurrence Inventory (FCRI-SF; scored 0-36, higher scores indicate greater fear of cancer recurrence) |
| Patient Health Questionnaire | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Patient Health Questionnaire (PHQ-8; scored 0-24, higher scores indicate worse depressive symptoms) |
| General Anxiety Disorder Anxiety Scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | General Anxiety Disorder Anxiety Scale (GAD-7; scored 0-21, higher scores indicate worse anxiety) |
| Acceptable, Appropriate, and Feasible | post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Patient-Reported Outcomes Measurement Information System Global Health: Mental Health | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Cholesterol | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Triglycerides | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| High Density Lipoprotein | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Low Density Lipoprotein | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Urea | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Albumin | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Creatinine | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Serum Cortisol | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Homocysteine | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| HbA1c | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Tumor Necrosis Factor Alpha | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Interleukin-6 | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Allostatic Load | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
| Nail Cortisol | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. |
| Patient-Reported Outcomes Measurement Information System Global Health: Physical Health | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | PRISM Intervention |
|---|---|
| Age, Continuous | 55 Years |
| Area Deprivation Index Least Deprived | 31 Participants |
| Area Deprivation Index Most Deprived | 10 Participants |
| Area Deprivation Index Unknown | 2 Participants |
| Cancer Stage Stage I | 2 Participants |
| Cancer Stage Stage II | 28 Participants |
| Cancer Stage Stage III | 3 Participants |
| Cancer Stage Stage IV - New Diagnosis | 5 Participants |
| Cancer Stage Stage IV - Recurrent Diagnosis | 5 Participants |
| Cancer Subtype HR-HER2- | 7 Participants |
| Cancer Subtype HR-HER2+ | 2 Participants |
| Cancer Subtype HR+HER2- | 20 Participants |
| Cancer Subtype HR+HER2+ | 12 Participants |
| Cancer Subtype HR-HER2 unknown | 1 Participants |
| Cancer Subtype HR+HER2 unknown | 1 Participants |
| Cancer Therapy Type Adjuvant | 11 Participants |
| Cancer Therapy Type Metastatic | 11 Participants |
| Cancer Therapy Type Neoadjuvant | 21 Participants |
| Education Advanced Degree | 11 Participants |
| Education Associate's Degree | 8 Participants |
| Education Bachelor's Degree | 5 Participants |
| Education High School Graduate/GED | 5 Participants |
| Education High School, No Degree | 2 Participants |
| Education Some College | 12 Participants |
| Employment Status Full-time | 13 Participants |
| Employment Status Not Employed | 17 Participants |
| Employment Status Part-time | 6 Participants |
| Employment Status Retired | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insurance Coverage Medicaid | 10 Participants |
| Insurance Coverage Medicaid/Medicare Dual Enrollment | 1 Participants |
| Insurance Coverage Medicare | 9 Participants |
| Insurance Coverage Other | 1 Participants |
| Insurance Coverage Private | 21 Participants |
| Insurance Coverage Veterans Administration/Military | 1 Participants |
| Martial Status Married/Partnered | 18 Participants |
| Martial Status Separated/Divorced | 18 Participants |
| Martial Status Single, Never Married | 5 Participants |
| Martial Status Widowed | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Rurality Rural | 2 Participants |
| Rurality Unknown | 1 Participants |
| Rurality Urban | 40 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Feasibility of PRISM
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
Time frame: 8 months 4 weeks
Population: Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRISM Intervention | Feasibility of PRISM | Completed both pre-post surveys and all 6 sessions | 33 Participants |
| PRISM Intervention | Feasibility of PRISM | Didn't complete PRISM | 10 Participants |
Secondary
Acceptable, Appropriate, and Feasible
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Acceptable, Appropriate, and Feasible | Acceptability of Intervention Measure (AIM) | 4.5 Scores on a scale | Standard Deviation 0.7 |
| PRISM Intervention | Acceptable, Appropriate, and Feasible | Intervention Appropriateness Measure (IAM) | 4.5 Scores on a scale | Standard Deviation 0.8 |
| PRISM Intervention | Acceptable, Appropriate, and Feasible | Feasibility of Intervention Measure (FIM) | 4.6 Scores on a scale | Standard Deviation 0.5 |
Secondary
Albumin
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Albumin | pre-PRISM | 4.2 g/dL | Standard Deviation 0.3 |
| PRISM Intervention | Albumin | post-PRISM | 4.3 g/dL | Standard Deviation 0.2 |
p-value: 0.618795% CI: [-0.6, 1]Paired t-Test
Secondary
Allostatic Load
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Allostatic Load | pre-PRISM | 3.9 Scores on a scale | Standard Deviation 1.4 |
| PRISM Intervention | Allostatic Load | post-PRISM | 3.7 Scores on a scale | Standard Deviation 1.7 |
p-value: 0.477195% CI: [-0.8, 0.4]Paired t-Test
Secondary
Cholesterol
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Cholesterol | pre-PRISM | 184.8 mg/dL | Standard Deviation 33.3 |
| PRISM Intervention | Cholesterol | post-PRISM | 196.9 mg/dL | Standard Deviation 53.4 |
p-value: 0.149795% CI: [-4.7, 29]Paired t-Test
Secondary
C-Reactive Protein
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRISM Intervention | C-Reactive Protein | pre-PRISM | Low Risk (<1 mg/L) | 2 Participants |
| PRISM Intervention | C-Reactive Protein | pre-PRISM | Average Risk (1-3 mg/L) | 10 Participants |
| PRISM Intervention | C-Reactive Protein | pre-PRISM | High Risk (>3 mg/L) | 13 Participants |
| PRISM Intervention | C-Reactive Protein | post-PRISM | Low Risk (<1 mg/L) | 2 Participants |
| PRISM Intervention | C-Reactive Protein | post-PRISM | Average Risk (1-3 mg/L) | 10 Participants |
| PRISM Intervention | C-Reactive Protein | post-PRISM | High Risk (>3 mg/L) | 13 Participants |
Secondary
Creatinine
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Creatinine | pre-PRISM | 1.1 mg/dL | Standard Deviation 0.3 |
| PRISM Intervention | Creatinine | post-PRISM | 1.2 mg/dL | Standard Deviation 0.4 |
p-value: 0.357295% CI: [-0.04, 0.1]Paired t-Test
Secondary
Fear of Cancer Recurrence Inventory
Fear of Cancer Recurrence Inventory (FCRI-SF; scored 0-36, higher scores indicate greater fear of cancer recurrence)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Fear of Cancer Recurrence Inventory | pre-PRISM | 17.9 Scores on a scale | Standard Deviation 7.1 |
| PRISM Intervention | Fear of Cancer Recurrence Inventory | post-PRISM | 15.4 Scores on a scale | Standard Deviation 7.1 |
p-value: 0.008295% CI: [-4.3, -0.7]Paired t-Test
Secondary
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being | pre-PRISM | 37.1 Scores on a scale | Standard Deviation 8.2 |
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being | post-PRISM | 40.5 Scores on a scale | Standard Deviation 5.4 |
p-value: 0.001295% CI: [1.5, 5.4]Paired t-Test
Secondary
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score | post-PRISM | 13.6 Scores on a scale | Standard Deviation 2.9 |
p-value: 0.049495% CI: [0, 1.4]Paired t-Test
Secondary
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score | pre-PRISM | 13.2 Scores on a scale | Standard Deviation 3 |
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score | post-PRISM | 14.5 Scores on a scale | Standard Deviation 1.7 |
p-value: 0.002195% CI: [0.5, 2]Paired t-Test
Secondary
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score | pre-PRISM | 11 Scores on a scale | Standard Deviation 3.4 |
| PRISM Intervention | Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score | post-PRISM | 12.5 Scores on a scale | Standard Deviation 2.6 |
p-value: 0.002795% CI: [0.6, 2.4]Paired t-Test
Secondary
General Anxiety Disorder Anxiety Scale
General Anxiety Disorder Anxiety Scale (GAD-7; scored 0-21, higher scores indicate worse anxiety)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | General Anxiety Disorder Anxiety Scale | pre-PRISM | 6.2 Scores on a scale | Standard Deviation 5.8 |
| PRISM Intervention | General Anxiety Disorder Anxiety Scale | post-PRISM | 5.1 Scores on a scale | Standard Deviation 4.4 |
p-value: 0.204695% CI: [-2.9, 0.6]Paired t-Test
Secondary
HbA1c
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRISM Intervention | HbA1c | pre-PRISM | Normal (<5.7%) | 9 Participants |
| PRISM Intervention | HbA1c | pre-PRISM | Pre-diabetic (5.7-6.4%) | 13 Participants |
| PRISM Intervention | HbA1c | pre-PRISM | Diabetic (>6.4%) | 3 Participants |
| PRISM Intervention | HbA1c | post-PRISM | Normal (<5.7%) | 11 Participants |
| PRISM Intervention | HbA1c | post-PRISM | Pre-diabetic (5.7-6.4%) | 9 Participants |
| PRISM Intervention | HbA1c | post-PRISM | Diabetic (>6.4%) | 5 Participants |
Secondary
High Density Lipoprotein
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | High Density Lipoprotein | pre-PRISM | 52.7 mg/dL | Standard Deviation 14.5 |
| PRISM Intervention | High Density Lipoprotein | post-PRISM | 56.3 mg/dL | Standard Deviation 15.6 |
p-value: 0.091595% CI: [-0.6, 7.7]Paired t-Test
Secondary
Homocysteine
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Homocysteine | pre-PRISM | 8.5 umol/L | Standard Deviation 3.7 |
| PRISM Intervention | Homocysteine | post-PRISM | 9.5 umol/L | Standard Deviation 4.7 |
p-value: 0.208895% CI: [-0.6, 2.5]Paired t-Test
Secondary
Interleukin-6
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Interleukin-6 | pre-PRISM | 1.7 pg/mL | Standard Deviation 1.9 |
| PRISM Intervention | Interleukin-6 | post-PRISM | 1.9 pg/mL | Standard Deviation 2.3 |
p-value: 0.638295% CI: [-0.8, 1.3]Paired t-Test
Secondary
Low Density Lipoprotein
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Low Density Lipoprotein | pre-PRISM | 107.4 mg/dL | Standard Deviation 26.1 |
| PRISM Intervention | Low Density Lipoprotein | post-PRISM | 112.6 mg/dL | Standard Deviation 41.4 |
p-value: 0.357395% CI: [-6.3, 16.9]Paired t-Test
Secondary
Nail Cortisol
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRISM Intervention | Nail Cortisol | pre-PRISM | Low (<=0.125) | 14 Participants |
| PRISM Intervention | Nail Cortisol | pre-PRISM | Moderate (0.126-0.724) | 3 Participants |
| PRISM Intervention | Nail Cortisol | pre-PRISM | High (>=0.725) | 6 Participants |
| PRISM Intervention | Nail Cortisol | pre-PRISM | unknown | 2 Participants |
| PRISM Intervention | Nail Cortisol | post-PRISM | Low (<=0.125) | 4 Participants |
| PRISM Intervention | Nail Cortisol | post-PRISM | Moderate (0.126-0.724) | 10 Participants |
| PRISM Intervention | Nail Cortisol | post-PRISM | High (>=0.725) | 4 Participants |
| PRISM Intervention | Nail Cortisol | post-PRISM | unknown | 7 Participants |
Secondary
Overall Post-Traumatic Growth Inventory
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Overall Post-Traumatic Growth Inventory | pre-PRISM | 57.4 Scores on a scale | Standard Deviation 28.7 |
| PRISM Intervention | Overall Post-Traumatic Growth Inventory | post-PRISM | 67.8 Scores on a scale | Standard Deviation 28.6 |
p-value: 0.016995% CI: [2, 18.8]Paired t-Test
Secondary
Patient Activation Measure
Patient Activation Measure (PAM; scored 0-100, higher scores indicate greater activation)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Patient Activation Measure | pre-PRISM | 41.3 Scores on a scale | Standard Deviation 5.4 |
| PRISM Intervention | Patient Activation Measure | post-PRISM | 41.9 Scores on a scale | Standard Deviation 5.2 |
p-value: 0.470795% CI: [-1.1, 2.3]Paired t-Test
Secondary
Patient Health Questionnaire
Patient Health Questionnaire (PHQ-8; scored 0-24, higher scores indicate worse depressive symptoms)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Patient Health Questionnaire | pre-PRISM | 6.4 Scores on a scale | Standard Deviation 5.4 |
| PRISM Intervention | Patient Health Questionnaire | post-PRISM | 5.2 Scores on a scale | Standard Deviation 4.3 |
p-value: 0.132795% CI: [-2.7, 0.4]Paired t-Test
Secondary
Patient-Reported Outcomes Measurement Information System Global Health: Mental Health
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Patient-Reported Outcomes Measurement Information System Global Health: Mental Health | pre-PRISM | 45.7 T-score | Standard Deviation 8.3 |
| PRISM Intervention | Patient-Reported Outcomes Measurement Information System Global Health: Mental Health | post-PRISM | 46.5 T-score | Standard Deviation 8.8 |
p-value: 0.456995% CI: [-1.3, 2.9]Paired t-Test
Secondary
Patient-Reported Outcomes Measurement Information System Global Health: Physical Health
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Patient-Reported Outcomes Measurement Information System Global Health: Physical Health | pre-PRISM | 44.7 T-score | Standard Deviation 9.1 |
| PRISM Intervention | Patient-Reported Outcomes Measurement Information System Global Health: Physical Health | post-PRISM | 44 T-score | Standard Deviation 8.6 |
p-value: 0.525295% CI: [-2.8, 1.4]Paired t-Test
Secondary
Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale | pre-PRISM | 9.5 Scores on a scale | Standard Deviation 4.8 |
| PRISM Intervention | Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale | post-PRISM | 10.5 Scores on a scale | Standard Deviation 4.7 |
p-value: 0.150695% CI: [-0.4, 2.5]Paired t-Test
Secondary
Post-Traumatic Growth Inventory: Improved Relationships Sub-scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Post-Traumatic Growth Inventory: Improved Relationships Sub-scale | pre-PRISM | 20 Scores on a scale | Standard Deviation 9.9 |
| PRISM Intervention | Post-Traumatic Growth Inventory: Improved Relationships Sub-scale | post-PRISM | 22.9 Scores on a scale | Standard Deviation 9.2 |
p-value: 0.026495% CI: [0.4, 5.5]Paired t-Test
Secondary
Post-Traumatic Growth Inventory: New Possibilities Sub-scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Post-Traumatic Growth Inventory: New Possibilities Sub-scale | pre-PRISM | 11 Scores on a scale | Standard Deviation 6.9 |
| PRISM Intervention | Post-Traumatic Growth Inventory: New Possibilities Sub-scale | post-PRISM | 14.5 Scores on a scale | Standard Deviation 7.1 |
p-value: 0.014495% CI: [0.7, 6.1]Paired t-Test
Secondary
Post-Traumatic Growth Inventory: Personal Strength Sub-scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Post-Traumatic Growth Inventory: Personal Strength Sub-scale | pre-PRISM | 10.9 Scores on a scale | Standard Deviation 6 |
| PRISM Intervention | Post-Traumatic Growth Inventory: Personal Strength Sub-scale | post-PRISM | 13.2 Scores on a scale | Standard Deviation 6.1 |
p-value: 0.016295% CI: [0.5, 4.3]Paired t-Test
Secondary
Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale | pre-PRISM | 6 Scores on a scale | Standard Deviation 3.7 |
| PRISM Intervention | Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale | post-PRISM | 6.7 Scores on a scale | Standard Deviation 3.7 |
p-value: 0.162295% CI: [-0.3, 1.6]Paired t-Test
Secondary
Resilience
Connor-Davidson Resilience scale (CD-RISC; scored 0-40, higher scores indicate greater resilience)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Resilience | post-PRISM | 31.8 Scores on a scale | Standard Deviation 5.6 |
| PRISM Intervention | Resilience | pre-PRISM | 28.5 Scores on a scale | Standard Deviation 7 |
p-value: 0.008995% CI: [0.9, 5.8]Paired t-Test
Secondary
Serum Cortisol
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Serum Cortisol | pre-PRISM | 7.7 mg/dL | Standard Deviation 4.3 |
| PRISM Intervention | Serum Cortisol | post-PRISM | 9.6 mg/dL | Standard Deviation 5.3 |
p-value: 0.10895% CI: [-0.5, 4.3]Paired t-Test
Secondary
Triglycerides
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Triglycerides | pre-PRISM | 123.4 mg/dL | Standard Deviation 80.4 |
| PRISM Intervention | Triglycerides | post-PRISM | 140 mg/dL | Standard Deviation 97.1 |
p-value: 0.216395% CI: [-10.4, 43.7]Paired t-Test
Secondary
Tumor Necrosis Factor Alpha
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Tumor Necrosis Factor Alpha | pre-PRISM | 1.4 pg/mL | Standard Deviation 0.6 |
| PRISM Intervention | Tumor Necrosis Factor Alpha | post-PRISM | 1.4 pg/mL | Standard Deviation 0.5 |
p-value: 0.733395% CI: [-0.1, 0.2]Paired t-Test
Secondary
Urea
Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRISM Intervention | Urea | pre-PRISM | 14.7 mg/dL | Standard Deviation 4.6 |
| PRISM Intervention | Urea | post-PRISM | 13.9 mg/dL | Standard Deviation 5.9 |
p-value: 0.374195% CI: [-2.8, 1.1]Paired t-Test