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Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
The University of Alabama
RECRUITING
Birmingham
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Contact Information
Primary
Erin Laurie-Zehr
erin_laurie@med.unc.edu
(919)-445-4941
Backup
Kacee Little
kacee_little@med.unc.edu
919-445-6199
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 120
Treatments
Experimental: PRISM
Participants with metastatic breast cancer (MBC) receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov