Breast CancerPRISM-MBCNCT06855654
Promoting Resilience in Women With Breast Cancer (PRISM -MBC)
A study testing Promoting Resilience in Women with Breast Cancer (PRISM) in people with Breast Cancer and Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Promoting Resilience in Women with Breast Cancer (PRISM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Participants are willing and able to comply with study procedures based on the judgement of the investigator.
- Male and female patients of age >18 years.
- Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date.
- Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English).
- Indicate intent to receive ongoing cancer care at the enrolling institution.
Who cannot join
- Individuals meeting any of the following exclusion criteria will be excluded from study participation.
- Patient unwilling or unable to complete surveys via one of the following methods: (a) paper survey completed in clinic or mailed directly to patient's home address, including a pre-addressed, pre-stamped return envelope in the mailed survey packet, or (b) electronic survey links sent via emails or text link on a mobile device, tablet, laptop, or desktop computer.
- Patient unwilling or unable to provide verbal or signed consent to participate.
- Participant cannot read English.
- Patient has permanently discontinued cancer-directed therapy or does not intend to receive any cancer-directed therapy, is receiving home or residential hospice care, is hospitalized, or is described as likely to die within 90 days or actively dying in last provider documentation, at the time of enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Alabama
Birmingham, Alabama, 35294
Gabrielle Rocque, MD, MSPH
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Erin Laurie-Zehr, MA, 919-445-6199, erin_laurie@med.unc.edu
Katie Reeder-Hayes, MD
About this study
Official title: Evaluating Psychological and Survival Outcomes of the Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC) Intervention
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM intervention in the MBC population.
Black women with MBC have shorter survival from the time of metastatic diagnosis to death, compared to White women with clinically similar disease, and may have more rapid declines in quality of life over time. Adverse social determinants of health may play a role in these outcome disparities, due to both social barriers in accessing care, and through direct stress-mediated biological effects on the host and tumor microenvironment. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; however, feasibility of face-to-face intervention during intensive medical treatment is limited. Thus, this study aims to demonstrate the feasibility of a remotely delivered resilience intervention, PRISM, already proven effective in other cancer settings, for MBC patients, and to gather preliminary efficacy data for a future randomized trial.
Read the detailed description
Black women with breast cancer have substantially worse survival compared to White counterparts across all stages of presenting disease. Survival from a diagnosis of metastatic breast cancer (MBC) to death is shorter for Black compared to non-Black women, with the worst disparity appearing in younger patients.
Black compared to non-Black MBC patients also report more chronic stressors including social barriers to cancer care, metabolic co-morbidities, and higher likelihood of residing in neighborhoods with adverse social determinants of health (SDOH). These bio-psycho-social factors are potential mechanisms of observed racial gaps in survival of MBC. The adversity experienced by Black patients may impact the outcomes of MBC through social, psychological, and biological mechanisms. Regarding social mechanisms, adverse SDOH may cause patients to have delays in care, miss appointments, defer needed treatment, or tolerate treatment less well due to unmet supportive care or social support needs. Regarding psychological and biological mechanisms, cumulative physiologic stress and distress elevate inflammatory and immune biomarkers and precipitate the development of cardio-metabolic diseases, a phenomenon known as allostatic overload. Black individuals both with and without cancer are more likely to suffer from allostatic overload, and the impact of cancer on allostatic load may be differential by race. While the Black-White gap in breast cancer survival has long been recognized, the relationships among marginalized racial identity, adverse social circumstances, allostatic overload, and breast cancer outcomes remain poorly understood.
Stress and Coping Theory posits that the ways in which individuals appraise and cope with stressful experiences are modifiable targets for intervention. In this regard, "resilience" is a key construct; it implies an ability to harness resources to sustain well-being in the face of adversity. In breast cancer patients and others with serious illness, skills in stress-management, goal-setting, positive-reframing, and meaning - making are associated with improved stress biology, physical, and mental health. In the context of an advanced cancer diagnosis, resilient individuals may be more able to cope with the challenges of illness, including barriers to care, and in turn experience less incremental stress, and improved quality of life (QOL) and disease outcomes. Such resilience might be particularly beneficial to patients from marginalized groups.
Investigators of this study have previously developed and demonstrated the efficacy of a targeted intervention promoting resilience in populations of young adults with pediatric cancers and advanced cancers. However, evidence is lacking as to whether such an intervention can be helpful among women with MBC, particularly those from historically marginalized communities. The goal of this study is to test the impacts of a remotely delivered resilience intervention, Promoting Resilience in Stress Management (PRISM), on relevant social, psychological, and biologic outcomes of diverse women with a recent diagnosis of MBC at the University of North Carolina-Chapel Hill (UNC) and the University of Alabama-Birmingham (UAB).
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- Promoting Resilience in Women with Breast Cancer (PRISM)
- Keywords
- Promoting Resilience in Women with Breast Cancer (PRISM), remote, Black women, adverse social determinants of health
- 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 Women with Breast Cancer (PRISM)Behavioural
PRISM is a brief, skills-based intervention targeting 4 core resilience resources (stress management, goal setting, cognitive reframing, and meaning-making) followed by an optional family session. This adapted version of the PRISM intervention will be delivered1:1 by trained coaches who speak English or Spanish via HIPAA-compliant video conference.A single coach conducts the program with a single patient. Each session is 30-60 minutes, for a total of 2- 4 hours. Sessions are delivered every 1-2 weeks per patient's preference. To facilitate on-demand skills-practice between sessions, all participants have access to the PRISM app, available for iOS/Android, and thus available to the >90% of U.S. adults who own a smartphone. Participants will be assisted to download the PRISM app to their device at the time of registration; however, coaches can also provide assistance with app access during intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| PRISM | Experimental | Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention. Receives: Behavioral: Promoting Resilience in Women with Breast Cancer (PRISM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience Score Change
Resilience Score Change will be assessed baseline to 3 months using Connor Davidson Resilience Score, overall and stratified by race (Black/non-Black).
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in allostatic load index (ALI)
Change in allostatic load index (ALI) including glycosylated Hgb, total cholesterol, HDL, LDL, triglycerides, high-sensitivity C-reactive protein, albumin and creatinine from pre- to post-intervention, overall, and stratified by race (Black/non-Black) will be reported.
Measured: Baseline and 12 months
Time to progression
Time to progression is the length of time from baseline until the disease begins to spread or worsen will be reported among PRISM participants, stratified by race.
Measured: Baseline and 12 months
Survival
Survival is defined as the time from baseline to date of death for any cause will be reported among PRISM participants, stratified by race.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Katie Reeder-Hayes, MD, MBA, MSCR, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855654
- Sponsor's protocol ID
- LCCC2424
- Acronym
- PRISM-MBC
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Psychological and Survival Outcomes of the Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC) Intervention
- ClinicalTrials.gov ID
- NCT06855654
- Acronym / sponsor ID
- PRISM-MBC / LCCC2424
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- Promoting Resilience in Women with Breast Cancer (PRISM), remote, Black women, adverse social determinants of health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM intervention in the MBC population.
Black women with MBC have shorter survival from the time of metastatic diagnosis to death, compared to White women with clinically similar disease, and may have more rapid declines in quality of life over time. Adverse social determinants of health may play a role in these outcome disparities, due to both social barriers in accessing care, and through direct stress-mediated biological effects on the host and tumor microenvironment. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; however, feasibility of face-to-face intervention during intensive medical treatment is limited. Thus, this study aims to demonstrate the feasibility of a remotely delivered resilience intervention, PRISM, already proven effective in other cancer settings, for MBC patients, and to gather preliminary efficacy data for a future randomized trial.
Detailed description
Black women with breast cancer have substantially worse survival compared to White counterparts across all stages of presenting disease. Survival from a diagnosis of metastatic breast cancer (MBC) to death is shorter for Black compared to non-Black women, with the worst disparity appearing in younger patients.
Black compared to non-Black MBC patients also report more chronic stressors including social barriers to cancer care, metabolic co-morbidities, and higher likelihood of residing in neighborhoods with adverse social determinants of health (SDOH). These bio-psycho-social factors are potential mechanisms of observed racial gaps in survival of MBC. The adversity experienced by Black patients may impact the outcomes of MBC through social, psychological, and biological mechanisms. Regarding social mechanisms, adverse SDOH may cause patients to have delays in care, miss appointments, defer needed treatment, or tolerate treatment less well due to unmet supportive care or social support needs. Regarding psychological and biological mechanisms, cumulative physiologic stress and distress elevate inflammatory and immune biomarkers and precipitate the development of cardio-metabolic diseases, a phenomenon known as allostatic overload. Black individuals both with and without cancer are more likely to suffer from allostatic overload, and the impact of cancer on allostatic load may be differential by race. While the Black-White gap in breast cancer survival has long been recognized, the relationships among marginalized racial identity, adverse social circumstances, allostatic overload, and breast cancer outcomes remain poorly understood.
Stress and Coping Theory posits that the ways in which individuals appraise and cope with stressful experiences are modifiable targets for intervention. In this regard, "resilience" is a key construct; it implies an ability to harness resources to sustain well-being in the face of adversity. In breast cancer patients and others with serious illness, skills in stress-management, goal-setting, positive-reframing, and meaning - making are associated with improved stress biology, physical, and mental health. In the context of an advanced cancer diagnosis, resilient individuals may be more able to cope with the challenges of illness, including barriers to care, and in turn experience less incremental stress, and improved quality of life (QOL) and disease outcomes. Such resilience might be particularly beneficial to patients from marginalized groups.
Investigators of this study have previously developed and demonstrated the efficacy of a targeted intervention promoting resilience in populations of young adults with pediatric cancers and advanced cancers. However, evidence is lacking as to whether such an intervention can be helpful among women with MBC, particularly those from historically marginalized communities. The goal of this study is to test the impacts of a remotely delivered resilience intervention, Promoting Resilience in Stress Management (PRISM), on relevant social, psychological, and biologic outcomes of diverse women with a recent diagnosis of MBC at the University of North Carolina-Chapel Hill (UNC) and the University of Alabama-Birmingham (UAB).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRISM | Experimental | Behavioral: Promoting Resilience in Women with Breast Cancer (PRISM)Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Participants are willing and able to comply with study procedures based on the judgement of the investigator.
- Male and female patients of age >18 years.
- Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date.
- Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English).
Key exclusion criteria (5 listed)
- Individuals meeting any of the following exclusion criteria will be excluded from study participation.
- Patient unwilling or unable to complete surveys via one of the following methods: (a) paper survey completed in clinic or mailed directly to patient's home address, including a pre-addressed, pre-stamped return envelope in the mailed survey packet, or (b) electronic survey links sent via emails or text link on a mobile device, tablet, laptop, or desktop computer.
- Patient unwilling or unable to provide verbal or signed consent to participate.
- Participant cannot read English.
- Patient has permanently discontinued cancer-directed therapy or does not intend to receive any cancer-directed therapy, is receiving home or residential hospice care, is hospitalized, or is described as likely to die within 90 days or actively dying in last provider documentation, at the time of enrollment.
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 Women with Breast Cancer (PRISM)PRISM is a brief, skills-based intervention targeting 4 core resilience resources (stress management, goal setting, cognitive reframing, and meaning-making) followed by an optional family session. This adapted version of the PRISM intervention will be delivered1:1 by trained coaches who speak English or Spanish via HIPAA-compliant video conference.A single coach conducts the program with a single patient. Each session is 30-60 minutes, for a total of 2- 4 hours. Sessions are delivered every 1-2 weeks per patient's preference. To facilitate on-demand skills-practice between sessions, all participants have access to the PRISM app, available for iOS/Android, and thus available to the >90% of U.S. adults who own a smartphone. Participants will be assisted to download the PRISM app to their device at the time of registration; however, coaches can also provide assistance with app access during intervention sessions. | Behavioural | PRISM |
Primary outcome
Resilience Score Change
Time frame: Baseline and 3 months
Resilience Score Change will be assessed baseline to 3 months using Connor Davidson Resilience Score, overall and stratified by race (Black/non-Black).
3 secondary outcomes
Change in allostatic load index (ALI)
Time frame: Baseline and 12 months
Time to progression
Time frame: Baseline and 12 months
Survival
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Katie Reeder-Hayes, MD, MBA, MSCR principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites 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 Women with Breast Cancer (PRISM) in people with Breast Cancer and Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Laurie-Zehr ((919)-445-4941, erin_laurie@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience Score Change (time frame: Baseline and 3 months). 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 15 May 2026.