PRISM Program for Breast Cancer
(PRISMMBC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.
What data supports the effectiveness of the PRISM treatment for breast cancer?
Is the PRISM Program for Breast Cancer safe for humans?
How does the PRISM treatment for breast cancer differ from other treatments?
The PRISM treatment is unique because it focuses on promoting resilience and managing stress in women with breast cancer, rather than directly targeting the cancer itself. It is similar to other supportive programs that aim to improve quality of life and reduce anxiety through mind-body-spirit approaches, but it specifically emphasizes building resilience.1231112
What is the purpose of this trial?
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.
Research Team
Katie Reeder-Hayes, MD, MBA, MSCR
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria
This trial is for men and women over 18 with a recent diagnosis of metastatic breast cancer, who can participate in English surveys and counseling. They must plan to continue treatment at the enrolling institution. It's not for those not seeking active treatment, in hospice care, hospitalized, or likely to pass away within 90 days.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the Promoting Resilience in Women with Breast Cancer (PRISM) intervention remotely
Follow-up
Participants are monitored for resilience score changes and other outcomes
Treatment Details
Interventions
- Promoting Resilience in Women with Breast Cancer (PRISM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University