This clinical trial evaluates the impact of BREAST-Q Real-time Engagement and Communication Tool (REACT) feedback on provider interactions, medical interventions and quality of life in patients undergoing breast surgery. Currently, patients complete standard questionnaires like the BREAST-Q and review the results with their provider as part of routine care. The BREAST-Q is a patient-reported outcome questionnaire that provides information about the impact and effectiveness of breast surgery. BREAST-Q REACT, an online patient portal, provides questionnaire feedback, information and recommendations in real-time. The BREAST-Q REACT portal may improve provider communications, medical interventions and overall quality of life in patients undergoing breast surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT06550401.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine the feasibility of a randomized controlled trial (RCT) investigating the impact of BREAST-Q REACT on patient-reported outcomes and provider engagement and interventions.
SECONDARY OBJECTIVES:
I. Determine the effect of BREAST-Q REACT enhanced feedback on patient-reported outcomes examining function and quality of life, which will be accomplished by summarizing the following, separately for the standard feedback and the BREAST-Q REACT groups:
Ia. BREAST-Q Physical Well-Being of the Chest scores at 2 weeks, 6 weeks, and 3 months postoperatively;
Ib. Quick Disabilities of the Arm, Shoulder and Hand (DASH) scores at 2 weeks, 6 weeks, and 3 months postoperatively.
II. Describe the proportion of patients who receive physical therapy referral separately by cohort and the time to physical therapy among patients who received a referral, defined as the time between the date of surgery and the date of first referral, separately for the standard feedback and the BREAST-Q REACT groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard questionnaire feedback from the BREAST-Q Physical Well-Being of the Chest and QuickDASH questionnaires preoperatively at baseline and postoperatively at 2 weeks, 6 weeks, and 3 months. Patients may receive a physical therapy referral per standard of care.
ARM II: Patients receive standard questionnaire feedback as in Arm I and also receive access to the BREAST-Q REACT feedback postoperatively at 2 weeks, 6 weeks, and 3 months. Patients may receive a physical therapy referral per standard of care.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJonas Nelson