This clinical trial tests the effect of a mindfulness and exercise program to improve the functional capability before surgery (pre-habilitation) in patients with bladder cancer undergoing surgery to remove all of the bladder and nearby tissues and organs (radical cystectomy). Post-surgery complications following a radical cystectomy remain high and can result in longer hospital stays or re-admissions to the hospital as well as increase the risk of death. Guided-imagery and mindfulness meditation, using techniques to help patients change the way they react to environmental triggers that may cause a negative reaction, has been shown to improve health-related quality of life, such as decreasing stress and anxiety. Pre-surgery exercise has been shown to have positive effects on heart function as well as muscle strength. Pre-habilitation with mindfulness and exercise may improve general health and well-being in patients with bladder cancer undergoing a radical cystectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT05790850.
Locations matching your search criteria
United States
Virginia
Charlottesville
University of Virginia Cancer CenterStatus: Active
Contact: Christine Ibilibor
Phone: 404-924-9558
PRIMARY OBJECTIVE:
I. To estimate the feasibility of implementing a pre-habilitation program in the care pathway of radical cystectomy (RC) patients.
SECONDARY OBJECTIVES:
I. To estimate the 4 weeks (+/- 2 weeks) post-operative complication rates in both the pre-habilitation program and usual care groups.
II. To assess patient-reported health-related quality of life, dispositional mindfulness, and perceived stress over time in both the pre-habilitation program and usual care groups.
III. To estimate measured peak oxygen uptake over time in both the pre-habilitation program and usual care groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in a pre-habilitation program that involves home based high-intensity cycling exercise sessions with a virtual-instructor and listening to guided-imagery and relaxation-based meditation recordings approximately 4 weeks before surgery on study. Patients receive fitness tracker to monitor activity and also undergo cardiopulmonary exercise testing (CPET) throughout study.
ARM II: Patients receive education on benefits of exercise prior to surgery and receive fitness tracker to monitor activity with instructions to log self-directed exercise sessions. Patients undergo CPET throughout study.
After completion of study treatment patients follow up 30 days after surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorChristine Ibilibor
