Promoting Resilience in Women With Breast Cancer (PRISM -MBC) (PRISM-MBC)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Promoting Resilience in Women with Breast Cancer (PRISM)

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Laurie-Zehr; Phone Number: (919)-445-4941; Email: erin_laurie@med.unc.edu
• Study Contact Backup: Name: Kacee Little; Phone Number: 919-445-6199; Email: kacee_little@med.unc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • The University of Alabama
      • Principal Investigator: Gabrielle Rocque, MD, MSPH
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
      • Contact: Erin Laurie-Zehr, MA; Phone Number: 919-445-6199; Email: erin_laurie@med.unc.edu
      • Principal Investigator: Katie Reeder-Hayes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PRISM; Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Pfizer
• Investigators: Principal Investigator: Katie Reeder-Hayes, MD, MBA, MSCR, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Black women; remote; Promoting Resilience in Women with Breast Cancer (PRISM); adverse social determinants of health
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: LCCC2424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No