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A Skills-based Intervention for Promoting Resilience in Stress Management for Patients with Metastatic Breast Cancer, PRISM-MBC Trial
Trial Status: active
This clinical trial evaluates the impact of a remotely delivered resilience intervention, Promoting Resilience in Stress Management (PRISM), on social, psychological, and biologic outcomes of Black women with a recent diagnosis of breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Black women with metastatic breast cancer (MBC) often survive for less time after metastatic diagnosis, compared to White women with similar disease. Black women may also have more rapid declines in quality of life over this period. Social barriers in accessing care and stress may play a role in these health outcomes. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes. PRISM is a brief, skills-based intervention targeting 4 core resilience resources (stress-management, goal-setting and problem-solving, positive re-appraisals of stressors, and meaning-making or benefit-finding) followed by an optional family session where recipients can share what they learned with loved ones and an optional session supporting advanced care planning. Participating in PRISM sessions may help improve quality of life and improves disease outcomes in Black women with MBC.
Inclusion Criteria
Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Participants is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
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
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. Provider confirmation of life expectancy is not required for enrollment
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06855654.
I. To evaluate the change in patient-reported resilience from pre- to post-intervention among Black and non-Black PRISM participants.
SECONDARY OBJECTIVES:
I. To evaluate the change in allostatic load index (ALI) from pre- to post-intervention among Black and non-Black PRISM participants.
II. To describe implementation outcomes of the PRISM resilience intervention among Black and non-Black participants in two oncology practices.
III. To describe the trajectory of patient-reported resilience over time from baseline to 12 months after receipt of PRISM intervention among Black and non-Black participants.
IV. To describe the trajectory of patient-reported mental health, quality of life, post-traumatic growth, and pain interference outcomes among PRISM participants, overall and stratified by race.
V. To describe biologic outcomes of MBC among PRISM participants, including disease progression, and survival overall and stratified by race.
EXPLORATORY OBJECTIVES:
I. To compare the trajectories of patient-reported resilience, mental health, quality of life, post-traumatic growth, and pain interference outcomes over 12 months among PRISM participants to trajectories of participants in a in a concurrent prospective observational cohort, the Patient Outcomes and Experiences in Metastatic Breast Cancer (POEM) study, for the same measures and timepoints as a non-randomized control group, overall and stratified by race.
II. To compare the trajectories of patient-reported outcomes over 12 months for PRISM participants with high versus low baseline health-related social needs and for those with versus without dependent children.
III. To generate preliminary estimates regarding the impact of PRISM on biologic outcomes of MBC, including disease progression, and survival, by non-randomized comparison to outcomes of participants in a concurrent prospective observational cohort, the POEM study.
OUTLINE:
Patients participate in 4 core module PRISM video sessions and up to 2 optional module PRISM video sessions over 30-60 minutes each once every 1-2 weeks up to 90 days. Patients may also participate in between-session skills practice via the PRISM app. Patients also undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at days 180 and 365.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
