This trial studies how well a web-based decision aid works in increasing engagement in surgery decision making in patients with newly diagnosed stage 0-III breast cancer. Web-based decision aids may help doctors learn more about how surgeons and breast cancer patients make decisions about breast cancer surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03766009.
PRIMARY OBJECTIVES:
I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.
II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.
SECONDARY OBJECTIVE:
I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.
OUTLINE: The determination of when an institution and their patients crossover to the intervention arm (Arm II) is randomized.
ARM I: Prior to institutional crossover, patients attend an audio-recorded breast cancer surgical consultation.
ARM II: Beginning 10 weeks after institutional crossover, patients attend an audio-recorded breast cancer surgical consultation. Patients also receive a web-based decision aid and telephone interview. Patients who accepted the web-based decision aid may attend an in-person or virtual interview and focus group.
After completion of study, patients are followed up within 3 weeks.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorHeather B. Neuman