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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Muscle-Invasive Bladder Carcinoma; Non-muscle-invasive Bladder Cancer
• Intervention / Treatment: Behavioral: Pre-operative physical exercise; Behavioral: Pre-operative mindfulness meditation practice

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Ibilibor; Phone Number: 4349240871; Email: ci5d@virginia.edu
• Study Contact Backup: Name: Francesca Whitefield; Phone Number: 4349240871; Email: fbw3mg@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Christine Ibilibor; Email: CI5D@virginia.edu
      • Contact: Ashley Byrne; Email: aeb6q@uvahealth.org
      • Contact: Christine Ibilibor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual preoperative care prior to radical cystectomy
Experimental: Intervention; Preoperative pre-habilitation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient-reported days devoted to solitary psychological support	Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group	30 days
Number of patient-reported days devoted to exercise	Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complication rate	Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively	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.	The EORTC QLQ BLM 30 consists of 30 questions developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The questionnaire was designed to be cancer-specific, multidimensional in structure, appropriate for self-administration, and applicable across a range of cultural settings. All of the scales and single-item measures range in score from 0 to 100. A higher score represents higher symptomatology in each respective domain.	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)	Maximal oxygen uptake will be measured using a cycle ergometer-based cardiopulmonary exercise testing (CPET).	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)	The Mindfulness Awareness Attention Scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Total scores range from 0 to 6; higher scores indicate higher dispositional mindfulness.	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)	the Perceived Stress Scale 10 (PSS 10) is a 10-item survey that captures the respondent's stress level in the past month and uses a Likert scale to assess different domains of stress. Individual scores on the PSS 10 can range from 0 to 40 with higher scores indicating higher perceived stress.	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: American Cancer Society, Inc.; Integrated Translational Health Research Institute of Virginia (iTHRIV)

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness; Meditation; Physical Exercise; Pre-habilitation
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: HSR210502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary of trial outcome data through publication or grant reporting requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No