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| ID | Type | Description | Link |
|---|---|---|---|
| 2027123 | Other Grant/Funding Number | Daiichi Sankyo |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRISM Intervention | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promoting Resilience in Stress Management Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of PRISM | Feasibility was defined as 70% of participants completing all sessions and pre/post surveys. | 8 months 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Affiliation | Role |
|---|---|---|
| Gabrielle Rocque, MD, MSPH | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of PRISM | Feasibility was defined as 70% of participants completing all sessions and pre/post surveys. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Count of Participants | Participants | 8 months 4 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Promoting Resilience in Stress Management Intervention: 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. |
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This pilot has several limitations as this was an initial feasibility study. The sample size was small and collected from a single site, there was not a control comparison, and the outcomes focused on feasibility. Thus, our study was not designed to evaluate efficacy. Additionally, sample heterogeneity could influence participants' psychological experiences while receiving PRISM intervention, and the sample size of this study did not permit sub-group analyses to address these differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabrielle Rocque, MD, MSPH | University of Alabama at Birmingham Cancer Center | 205-996-9281 | grocque@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2024 | Sep 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| post-PRISM (ranged from 1 to 7 months after baseline) |
| Resilience | Connor-Davidson Resilience scale (CD-RISC; scored 0-40, higher scores indicate greater resilience) | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Patient Activation Measure | Patient Activation Measure (PAM; scored 0-100, higher scores indicate greater activation) | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Fear of Cancer Recurrence Inventory | Fear of Cancer Recurrence Inventory (FCRI-SF; scored 0-36, higher scores indicate greater fear of cancer recurrence) | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Patient Health Questionnaire | Patient Health Questionnaire (PHQ-8; scored 0-24, higher scores indicate worse depressive symptoms) | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| General Anxiety Disorder Anxiety Scale | General Anxiety Disorder Anxiety Scale (GAD-7; scored 0-21, higher scores indicate worse anxiety) | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Cholesterol | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Triglycerides | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| High Density Lipoprotein | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Low Density Lipoprotein | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Urea | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Albumin | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Creatinine | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Serum Cortisol | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Homocysteine | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| HbA1c | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| C-Reactive Protein | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Tumor Necrosis Factor Alpha | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Interleukin-6 | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| 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. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Nail Cortisol | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
| Withdrawal by Subject |
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| Years |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Education | Highest level of education obtained at the start of the intervention | Count of Participants | Participants |
|
| Martial Status | Count of Participants | Participants |
|
| Employment Status | Employment status at the start of the intervention | Count of Participants | Participants |
|
| Insurance Coverage | Insurance coverage at the start of the intervention | Count of Participants | Participants |
|
| Rurality | Rurality is derived from Rural-Urban Commuting Area (RUCA) codes created using the participant's place of residence | Count of Participants | Participants |
|
| Area Deprivation Index | More deprived neighborhoods are link to worse health outcomes when compared to those in neighborhoods that are less deprived. Index is based on the participant's place of residence. | Count of Participants | Participants |
|
| Cancer Therapy Type | Count of Participants | Participants |
|
| Cancer Stage | Cancer stage was captured from the participant's electronic medical record which utilizes the American Joint Committee on Cancer (AJCC) TNM system. The TNM system take into account tumor size, if cancer has spread to lymph nodes, and metastasis to distant organs. Stage numbers often represent the degree to which cancer has spread. A lower stage number indicates a more early-stage cancer that generally has a good prognosis. As the stage number increases, the cancer becomes more advanced and more difficult to treat. | Count of Participants | Participants |
|
| Cancer Subtype | HR is hormone receptor and can be positive or negative. HR+ indicates that tumor cells have receptors for estrogen and progesterone that promotes tumor growth. HR- indicates that tumor cells do not have hormone receptors. HER2 is human epidermal growth factor receptor 2 and can be positive of negative. HER2+ indicates that tumor cells have higher levels of HER2/neu and is associate with more aggressive breast cancers. | Count of Participants | Participants |
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| Sex: Female, Male | Only females were recruited. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | post-PRISM (ranged from 1 to 7 months after baseline) |
|
|
|
| Secondary | Resilience | Connor-Davidson Resilience scale (CD-RISC; scored 0-40, higher scores indicate greater resilience) | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
|
|
|
|
| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
|
|
|
|
| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
|
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| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
|
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| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
|
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| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Out of 43 participants, only 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Patient Activation Measure | Patient Activation Measure (PAM; scored 0-100, higher scores indicate greater activation) | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Fear of Cancer Recurrence Inventory | Fear of Cancer Recurrence Inventory (FCRI-SF; scored 0-36, higher scores indicate greater fear of cancer recurrence) | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Patient Health Questionnaire | Patient Health Questionnaire (PHQ-8; scored 0-24, higher scores indicate worse depressive symptoms) | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | General Anxiety Disorder Anxiety Scale | General Anxiety Disorder Anxiety Scale (GAD-7; scored 0-21, higher scores indicate worse anxiety) | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | T-score | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | Of 43 participants, 33 completed both surveys to obtain a pre/post value for each measure. | Posted | Mean | Standard Deviation | T-score | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Cholesterol | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Triglycerides | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | High Density Lipoprotein | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Low Density Lipoprotein | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Urea | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Albumin | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | g/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Creatinine | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Serum Cortisol | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | mg/dL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Homocysteine | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | umol/L | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | HbA1c | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Count of Participants | Participants | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | C-Reactive Protein | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Count of Participants | Participants | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Tumor Necrosis Factor Alpha | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | pg/mL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Interleukin-6 | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Mean | Standard Deviation | pg/mL | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| Secondary | Nail Cortisol | Biomarker samples were taken prior to and approximately one month after the last PRISM intervention session. | 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. | Posted | Count of Participants | Participants | pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline) |
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| 3 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
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| post-PRISM |
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| post-PRISM |
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| unknown |
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| post-PRISM |
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