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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05790850
Status
Recruiting

Conditions

  • Bladder Cancer
  • Muscle-Invasive Bladder Carcinoma
  • Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Pre-operative physical exercise — BEHAVIORAL
    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.
  • Pre-operative mindfulness meditation practice — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 30, 2023
Status verified
Dec 2024
Primary completion
Oct 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control
    Usual preoperative care prior to radical cystectomy
  • Experimental: Intervention
    Preoperative pre-habilitation

Primary Outcome Measure

Number of patient-reported days devoted to solitary psychological support [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Christine Ibilibor
Ashley Byrne
Christine Ibilibor, MD

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