Breast CancerPRISMNCT06133348
Promoting Resilience in Women With Breast Cancer
A study testing Promoting Resilience in Stress Management Intervention in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Promoting Resilience in Stress Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer
Who cannot join
- patients who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Promoting Resilience in Stress Management Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Resilience in Stress Management InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PRISM Intervention | Experimental | 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. Receives: Behavioral: Promoting Resilience in Stress Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of PRISM
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
Measured: 8 months 4 weeks
Secondary outcomes (33)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-PRISM (Baseline) and post-PRISM (ranged from 1 to 7 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start24 Jan 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabrielle Rocque, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133348
- Sponsor's protocol ID
- 300011028
- Other IDs
- 2027123
- Acronym
- PRISM
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2023
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Resilience in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06133348
- Acronym / sponsor ID
- PRISM / 300011028
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRISM Intervention | Experimental | Behavioral: Promoting Resilience in Stress Management InterventionThis 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer
Key exclusion criteria (1 listed)
- patients who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Resilience in Stress Management InterventionPRISM 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. | Behavioural | PRISM Intervention |
Primary outcome
Feasibility of PRISM
Time frame: 8 months 4 weeks
Feasibility was defined as 70% of participants completing all sessions and pre/post surveys.
33 secondary outcomes
Acceptable, Appropriate, and Feasible
Time frame: 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)
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: Personal Strength Sub-scale
Time frame: 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: Improved Relationships Sub-scale
Time frame: 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: Appreciation for Life Sub-scale
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
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
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
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
Time frame: 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)
Fear of Cancer Recurrence Inventory
Time frame: 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)
General Anxiety Disorder Anxiety Scale
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
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
Time frame: 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)
Triglycerides
Time frame: 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)
Low Density Lipoprotein
Time frame: 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)
Albumin
Time frame: 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)
Serum Cortisol
Time frame: 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)
HbA1c
Time frame: 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)
Tumor Necrosis Factor Alpha
Time frame: 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)
Allostatic Load
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Resilience in Stress Management Intervention in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of PRISM (time frame: 8 months 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.