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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
43
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.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Feasibility of PRISM
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
Time frame: 8 months 4 weeks
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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