RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-30
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05790850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female, aged ≥18 years of age
  4. * Good surgical candidate determined by treating surgeon
  5. * 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
  6. * Adequate Organ Function per protocol definition
  7. * ECOG performance status ≤2
  8. * Received medical clearance to complete cardiopulmonary exercise testing
  9. * Willing to use the personal or study provided devices for monitoring and performing the exercise routines.
  10. * Fluent in English or Spanish for the EORTC QLQ questionnaire
  11. * No known contraindications to high intensity exercise
  1. * Contraindications to participating in aerobic exercise
  2. * Currently participating in an aerobic exercise program
  3. * New onset chest pain nor dyspnea with exertion
  4. * Histologically documented micropapillary or sarcomatoid bladder cancer
  5. * Distant metastatic carcinoma

Contacts and Locations

Study Contact

Christine Ibilibor
CONTACT
4349240871
ci5d@virginia.edu
Ashley Byrne
CONTACT
4349240871
aeb6q@uvahealth.org

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-30
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-03-30
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Meditation
  • Physical Exercise
  • Pre-habilitation

Additional Relevant MeSH Terms

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