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Completed

NCT Number: NCT06133348

Promoting Resilience in Women With Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of PRISM

    Time frame: 8 months 4 weeks

    Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.

Secondary outcomes

  1. Acceptable, Appropriate, and Feasible

    Time frame: 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.

  2. Resilience

    Time frame: 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)

  3. Overall Post-Traumatic Growth Inventory

    Time frame: 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.

  4. Post-Traumatic Growth Inventory: Personal Strength Sub-scale

    Time frame: 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.

  5. Post-Traumatic Growth Inventory: New Possibilities Sub-scale

    Time frame: 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.

  6. Post-Traumatic Growth Inventory: Improved Relationships Sub-scale

    Time frame: 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.

  7. Post-Traumatic Growth Inventory: Spiritual Growth Sub-scale

    Time frame: 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.

  8. Post-Traumatic Growth Inventory: Appreciation for Life Sub-scale

    Time frame: 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.

  9. Functional Assessment of Chronic Illness Therapy Spiritual Well-Being

    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 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.

  10. Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Meaning 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 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.

  11. Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Peace 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 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.

  12. Functional Assessment of Chronic Illness Therapy Spiritual Well-Being: Faith 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 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.

  13. Patient Activation Measure

    Time frame: 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)

  14. Fear of Cancer Recurrence Inventory

    Time frame: 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)

  15. Patient Health Questionnaire

    Time frame: 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)

  16. General Anxiety Disorder Anxiety Scale

    Time frame: 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)

  17. Patient-Reported Outcomes Measurement Information System Global Health: 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 - 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.

  18. Patient-Reported Outcomes Measurement Information System Global Health: Mental 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 (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.

  19. Cholesterol

    Time frame: 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.

  20. Triglycerides

    Time frame: 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.

  21. High Density Lipoprotein

    Time frame: 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.

  22. Low Density Lipoprotein

    Time frame: 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.

  23. Urea

    Time frame: 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.

  24. Albumin

    Time frame: 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.

  25. Creatinine

    Time frame: 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.

  26. Serum Cortisol

    Time frame: 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.

  27. Homocysteine

    Time frame: 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.

  28. HbA1c

    Time frame: 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.

  29. C-Reactive Protein

    Time frame: 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.

  30. Tumor Necrosis Factor Alpha

    Time frame: 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.

  31. Interleukin-6

    Time frame: 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.

  32. Allostatic Load

    Time frame: 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.

  33. Nail Cortisol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: PRISM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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