Recruiting

PRISM - MBC

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06855654

Conditions

Breast Cancer

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Promoting Resilience in Women with Breast Cancer (PRISM)

Study Details

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

Study ID

NCT06855654

Start date

Jan 1, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PRISM

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

Interventions

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.

Primary outcome measure

  • Resilience Score Change [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Erin Laurie-Zehr

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

Kacee Little

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

Locations

The University of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Gabrielle Rocque, MD, MSPH

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Erin Laurie-Zehr, MA

919-445-6199erin_laurie@med.unc.edu

Principal Investigator:

Katie Reeder-Hayes, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-05-15.