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Recruiting NCT05790850

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

No phase Interventional Bladder Cancer Non-muscle-invasive Bladder Cancer Muscle-Invasive Bladder Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-operative physical exercise, Pre-operative mindfulness meditation practice.
Who it may be relevant to
Registry conditions: Bladder Cancer, Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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 measures

  • 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]
Secondary outcome measures (5)
  • Post-operative complication rate [Time frame: 30 days post-operatively]
  • Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire. [Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]
  • Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET) [Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]
  • Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS) [Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]
  • Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10) [Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT05790850 · HSR210502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗