Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pre-operative physical exercise
- Pre-operative mindfulness meditation practice
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Virginia
Lead sponsor
American Cancer Society, Inc.
Collaborator
Integrated Translational Health Research Institute of Virginia (iTHRIV)
Collaborator
Source ClinicalTrials.gov