Promoting Resilience in Women With Breast Cancer (PRISM)

October 25, 2025 updated by: Gabrielle Rocque, University of Alabama at Birmingham
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of PRISM
Time Frame: 8 months 4 weeks
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
8 months 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
post-PRISM (ranged from 1 to 7 months after baseline)
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)
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
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
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.
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
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.
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
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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)
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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)
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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)
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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)
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
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.
pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabrielle Rocque, MD, MSPH, The University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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