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Exercise + Mindfulness for Bladder Cancer (PRIMER Trial)

N/A
Recruiting
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Awards & highlights

PRIMER Trial Summary

This trial tests an exercise and mindfulness program to help bladder cancer patients get physically and mentally ready for surgery.

Who is the study for?
This trial is for adults over 18 with various types of bladder cancer who are fit for surgery, have good organ function, and can do high-intensity exercise. They must be able to follow the study plan, use devices for exercise monitoring, and understand English or Spanish. People with new chest pain, breathing issues during exertion, distant cancer spread, or those already in an aerobic program cannot join.Check my eligibility
What is being tested?
The PRIMER trial tests a home-based pre-surgery program combining physical exercises and mindfulness meditation to improve patients' physical and mental state before radical cystectomy (bladder removal). It's designed to see if this 'pre-habilitation' approach is practical.See study design
What are the potential side effects?
Since the interventions involve exercise and meditation practices rather than medications, side effects may include typical exercise-related risks such as muscle strain or injury. Meditation is generally low-risk but could potentially cause discomfort for some individuals.

PRIMER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but might not be able to do heavy physical work.

PRIMER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patient-reported days devoted to exercise
Number of patient-reported days devoted to solitary psychological support
Secondary outcome measures
Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)
Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)
+2 more

PRIMER Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Preoperative pre-habilitation
Group II: ControlActive Control1 Intervention
Usual preoperative care prior to radical cystectomy

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,043 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,425 Total Patients Enrolled
Integrated Translational Health Research Institute of Virginia (iTHRIV)UNKNOWN

Media Library

Pre-operative mindfulness meditation practice Clinical Trial Eligibility Overview. Trial Name: NCT05790850 — N/A
Bladder Cancer Research Study Groups: Control, Intervention
Bladder Cancer Clinical Trial 2023: Pre-operative mindfulness meditation practice Highlights & Side Effects. Trial Name: NCT05790850 — N/A
Pre-operative mindfulness meditation practice 2023 Treatment Timeline for Medical Study. Trial Name: NCT05790850 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for this clinical trial limited to individuals aged 80 and under?

"This medical trial seeks volunteers aged 18 years or older, and not exceeding 90 years of age."

Answered by AI

What criteria must be met in order to qualify for participation in this research project?

"To participate in this clinical trial, applicants should present with bladder cancer and fall between 18 to 90 years of age. The study aims to include 30 qualified participants."

Answered by AI

Does this research program need more participants?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently recruiting participants since its inception on March 1st 2023 and last update on the 28th of the same month. The experiment requires 30 people from a single site for enrollment."

Answered by AI

What is the cap on total participants in this research?

"Affirmative. According to clinicaltrials.gov, this research effort is actively on the lookout for suitable individuals since it was initially launched in March 1st 2023 and last updated by March 28th 2023. A total of 30 participants are needed across one clinical centre."

Answered by AI

What are the primary goals of this medical experiment?

"This 30-day study aims to quantify the number of days patients dedicate to exercise. Secondary objectives are focused on assessing health-related quality of life, peak oxygen uptake during cardiopulmonary exercise testing (CPET), and levels of dispositional mindfulness as measured by the Mindfulness Awareness Attention Scale (MAAS). The EORTC QLQ BLM 30 is a questionnaire developed specifically for cancer patients that considers five functional scales, three symptom scales, several single-item measures commonly reported by cancer sufferers, and perceived financial impact; while MAAS is a 15 item scale designed to assess receptivity in terms of attention towards what's occurring"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Christine Ibilibor, MD 2023. "Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05790850.
~15 spots leftby Jun 2025
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