N/A
N=43
Promoting Resilience in Women With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06133348 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Feasibility of PRISM — 33; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Promoting Resilience in Stress Management Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of PRISM |
33; 10 | — |
| SECONDARY Acceptable, Appropriate, and Feasible |
4.5; 4.5; 4.6 | — |
| SECONDARY Resilience |
28.5; 31.8 | 0.0089 sig |
| SECONDARY Overall Post-Traumatic Growth Inventory |
57.4; 67.8 | 0.0169 sig |
| SECONDARY Post-Traumatic Growth Inventory: Personal Strength Sub-scale |
10.9; 13.2 | 0.0162 sig |
| SECONDARY Post-Traumatic Growth Inventory: New Possibilities Sub-scale |
11; 14.5 | 0.0144 sig |
| SECONDARY Post-Traumatic Growth Inventory: Improved Relationships Sub-scale |
20; 22.9 | 0.0264 sig |
| SECONDARY Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale |
6; 6.7 | 0.1622 |
| SECONDARY Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale |
9.5; 10.5 | 0.1506 |
| SECONDARY Functional Assessment of Chronic Illness Therapy Spiritual Well-Being |
37.1; 40.5 | 0.0012 sig |
| SECONDARY Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning Sub-score |
13.2; 14.5 | 0.0021 sig |
| SECONDARY Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace Sub-score |
11; 12.5 | 0.0027 sig |
| SECONDARY Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith Sub-score |
12.9; 13.6 | 0.0494 sig |
| SECONDARY Patient Activation Measure |
41.3; 41.9 | 0.4707 |
| SECONDARY Fear of Cancer Recurrence Inventory |
17.9; 15.4 | 0.0082 sig |
| SECONDARY Patient Health Questionnaire |
6.4; 5.2 | 0.1327 |
| SECONDARY General Anxiety Disorder Anxiety Scale |
6.2; 5.1 | 0.2046 |
| SECONDARY Patient-Reported Outcomes Measurement Information System Global Health: Physical Health |
44.7; 44 | 0.5252 |
| SECONDARY Patient-Reported Outcomes Measurement Information System Global Health: Mental Health |
45.7; 46.5 | 0.4569 |
| SECONDARY Cholesterol |
184.8; 196.9 | 0.1497 |
| SECONDARY Triglycerides |
123.4; 140 | 0.2163 |
| SECONDARY High Density Lipoprotein |
52.7; 56.3 | 0.0915 |
| SECONDARY Low Density Lipoprotein |
107.4; 112.6 | 0.3573 |
| SECONDARY Urea |
14.7; 13.9 | 0.3741 |
| SECONDARY Albumin |
4.2; 4.3 | 0.6187 |
| SECONDARY Creatinine |
1.1; 1.2 | 0.3572 |
| SECONDARY Serum Cortisol |
7.7; 9.6 | 0.1080 |
| SECONDARY Homocysteine |
8.5; 9.5 | 0.2088 |
| SECONDARY HbA1c |
9; 13; 3; 11; 9; 5 | — |
| SECONDARY C-Reactive Protein |
2; 10; 13; 2; 10; 13 | — |
| SECONDARY Tumor Necrosis Factor Alpha |
1.4; 1.4 | 0.7333 |
| SECONDARY Interleukin-6 |
1.7; 1.9 | 0.6382 |
| SECONDARY Allostatic Load |
3.9; 3.7 | 0.4771 |
| SECONDARY Nail Cortisol |
14; 3; 6; 2; 4; 10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06133348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.