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

NCT06855654 | Recruiting DMC

• 1 other identifier: LCCC2424
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Keywords

Promoting Resilience in Women with Breast Cancer (PRISM); remote; Black women; adverse social determinants of health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in allostatic load index (ALI)

  Baseline and 12 months

• Time to progression

  Baseline and 12 months

• Survival

  Baseline and 12 months

Study Arms (1)

PRISM

EXPERIMENTAL

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)

Interventions

Promoting Resilience in Women with Breast Cancer (PRISM) BEHAVIORAL

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.

PRISM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Pfizer: collaborator

Study Sites (2)

The University of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Katie Reeder-Hayes, MD, MBA, MSCR

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Laurie-Zehr

CONTACT

(919)-445-4941; erin_laurie@med.unc.edu

Kacee Little

CONTACT

919-445-6199; kacee_little@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)