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

December 10, 2024 updated by: Christine Ibilibor, MD, University of Virginia
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patient-reported days devoted to solitary psychological support
Time Frame: 30 days
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
Time Frame: 30 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-operative complication rate
Time Frame: 30 days post-operatively
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.
Time Frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
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)
Time Frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
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)
Time Frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
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)
Time Frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.
Integrated Translational Health Research Institute of Virginia (iTHRIV)

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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