Promoting Resilience in Women With Breast Cancer (PRISM)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Promoting Resilience in Stress Management 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Gabrielle Rocque, MD, MSPH, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 300011028; 2027123 (Other Grant/Funding Number: Daiichi Sankyo)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No