RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06855654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. * Participants are willing and able to comply with study procedures based on the judgement of the investigator.
  3. * Male and female patients of age \>18 years.
  4. * Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date.
  5. * Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English).
  6. * Indicate intent to receive ongoing cancer care at the enrolling institution.
  1. * 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.
  2. * Patient unwilling or unable to provide verbal or signed consent to participate.
  3. * Participant cannot read English.
  4. * 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.

Contacts and Locations

Study Contact

Erin Laurie-Zehr
CONTACT
(919)-445-4941
erin_laurie@med.unc.edu
Kacee Little
CONTACT
919-445-6199
kacee_little@med.unc.edu

Principal Investigator

Katie Reeder-Hayes, MD, MBA, MSCR
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

The University of Alabama
Birmingham, Alabama, 35294
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Katie Reeder-Hayes, MD, MBA, MSCR, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer
  • Metastatic Breast Cancer