Clinical trial NCT06855654: Promoting Resilience in Women With Breast Cancer (PRISM -MBC)
Official title: Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Metastatic Breast Cancer
Keywords: Promoting Resilience in Women with Breast Cancer (PRISM)
remote
Black women
adverse social determinants of health
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2025-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Resilience Score Change
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in allostatic load index (ALI)
timeFrame: Baseline and 12 months
measure: Time to progression
timeFrame: Baseline and 12 months
measure: Survival
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama
state: Alabama
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Katie Reeder-Hayes, MD, MBA, MSCR
role: PRINCIPAL_INVESTIGATOR
References: