Recruiting

Mindfulness & Exercise

Sponsor:

University of Virginia

Code:

NCT05790850

Conditions

Bladder Cancer

Non-muscle-invasive Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pre-operative physical exercise

Pre-operative mindfulness meditation practice

Study Details

Brief 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.

Conditions

Bladder Cancer

Non-muscle-invasive Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Study ID

NCT05790850

Start date

Mar 30, 2023

Status verified date

Dec, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Usual preoperative care prior to radical cystectomy

experimental: Intervention

Preoperative pre-habilitation

Interventions

Pre-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.

Pre-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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christine Ibilibor

4349240871ci5d@virginia.edu

Francesca Whitefield

4349240871fbw3mg@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Christine Ibilibor

CI5D@virginia.edu

Ashley Byrne

aeb6q@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Keywords

  • Mindfulness
  • Meditation
  • Physical Exercise
  • Pre-habilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-12-16.