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

University of Virginia

Status: Enrolling

Conditions: Bladder Cancer; Non-muscle-invasive Bladder Cancer; Muscle-Invasive Bladder Carcinoma

Treatments: Behavioral: Pre-operative physical exercise; Behavioral: Pre-operative mindfulness meditation practice

Study type: Interventional

Funder types: Other

Identifiers

NCT05790850

HSR210502

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control

No Intervention group

Description:

Usual preoperative care prior to radical cystectomy

Intervention

Experimental group

Description:

Preoperative pre-habilitation

Treatment:

Behavioral: Pre-operative mindfulness meditation practice

Behavioral: Pre-operative physical exercise