This clinical trial assesses a group-education based intervention called Acting on Cancer Testing-Together (ACT-Together) for improving adherence to recommend surveillance and risk-reducing procedures in patients with BRCA 1 and 2 mutations (changes). BRCA 1 and 2 are hereditary cancer predisposition syndromes and account for up to 3-10% of breast and ovarian cancers. For women with breast cancer genes (BRCA) 1 and 2, adherence to recommended surveillance and use of risk reducing surgery can decrease the risk of cancer-related death, yet use of these strategies remains low. Group-based interventions have been successfully used to improve compliance with breast cancer and cervical cancer screening in diverse populations. This study may help researchers learn whether the ACT-Together intervention may improve adherence to recommended surveillance and risk-reducing procedures in patients with BRCA 1 and 2 mutations.
Additional locations may be listed on ClinicalTrials.gov for NCT06549153.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess the feasibility benchmarks of this intervention by estimating:
Ia. The enrollment of participants over a 3-month period;
Ib. Attendance of participants randomized to the ACT-Together intervention;
Ic. Completion of baseline and follow up surveys.
SECONDARY OBJECTIVES:
I. Increase breast cancer screening rates or intention to undergo breast cancer screening.
II. Increase uptake of risk-reducing bilateral salpino-oophorectomy (rrBSO) or intention to undergo rrBSO.
III. Demonstrate increase in perceived susceptibility and benefits to risk reducing interventions, and decreased barriers as measured by the Revised Champion Health Belief Scale.
EXPLORATORY OBJECTIVE:
I. Participant satisfaction with the ACT-Together intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients participate in the ACT-Together intervention consisting of virtual group-based education sessions over 90 minutes. Sessions consist of the following concepts: review cancer risks associated with BRCA 1 and 2 mutations, review recommended screening schedules for each genetic condition, and review recommended risk reducing interventions (surgical and medical) and their recommended timing.
ARM B: Patients receive standard of care (SOC) and access to educational videos that review the same content covered in the ACT-Together intervention on study.
After completion of study intervention, patients are followed up at 6 and 12 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJose Alejandro Rauh-Hain
