RecruitingInterventional

Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

NCT ID: NCT05790850Sponsor: University of VirginiaLast updated: 2024-12-16

Summary

The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.

Arms & interventions

BehavioralPre-operative physical exercise
Virtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.
BehavioralPre-operative mindfulness meditation practice
Daily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.

Outcome measures

Primary

Number of patient-reported days devoted to solitary psychological support
Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group
Time frame: 30 days
Number of patient-reported days devoted to exercise
Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group
Time frame: 30 days

Secondary

Post-operative complication rate
Time frame: 30 days post-operatively
Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)
Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)
Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)
Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

Eligibility criteria

Sex: AllAge: 18 Years to 90 YearsHealthy volunteers: No

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 years of age * Good surgical candidate determined by treating surgeon * Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology * Adequate Organ Function per protocol definition * ECOG performance status ≤2 * Received medical clearance to complete cardiopulmonary exercise testing * Willing to use the personal or study provided devices for monitoring and performing the exercise routines. * Fluent in English or Spanish for the EORTC QLQ questionnaire * No known contraindications to high intensity exercise Exclusion Criteria: * Contraindications to participating in aerobic exercise * Currently participating in an aerobic exercise program * New onset chest pain nor dyspnea with exertion * Histologically documented micropapillary or sarcomatoid bladder cancer * Distant metastatic carcinoma

Study locations (1)

University of Virginia

Charlottesville, Virginia, 22903

Recruiting

Christine Ibilibor · Contact

CI5D@virginia.edu

Ashley Byrne · Contact

aeb6q@uvahealth.org

Christine Ibilibor, MD · Contact