Exercise + Mindfulness for Bladder Cancer

(PRIMER Trial)

Overseen By Francesca Whitefield

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Micropapillary, Sarcomatoid, Metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home-based exercise and mindfulness program can improve the physical and mental well-being of patients preparing for bladder cancer surgery. The study includes two groups: one receiving usual pre-surgery care and another trying a new pre-habilitation program, which involves pre-operative mindfulness meditation and physical exercise. It seeks participants with specific types of bladder cancer who are suitable for surgery and can engage in physical activity. Participants should be prepared to use devices to track their exercise and must understand English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance recovery and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this pre-habilitation program is safe for patients undergoing radical cystectomy?

Research shows that mindfulness meditation is safe and helpful for people preparing for surgery. Some studies have found that practicing mindfulness can reduce pain, anxiety, and stress, leading to a smoother recovery. No major safety concerns have been reported with mindfulness, making it a well-tolerated option for many.

Regarding exercise, studies indicate that exercising before surgery is generally safe and can aid recovery. It can increase strength and endurance. Research has not identified significant safety issues, suggesting it is well-tolerated by most patients.

Both mindfulness meditation and exercise are non-invasive and have good safety records, meaning they are unlikely to cause harm when done as instructed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining pre-operative mindfulness meditation and physical exercise for bladder cancer because these approaches offer a fresh perspective on patient preparation. Unlike traditional treatments that primarily focus on surgery and chemotherapy, this method aims to enhance overall patient well-being and resilience before surgery. Mindfulness meditation can help reduce stress and anxiety, potentially improving surgical outcomes, while physical exercise may boost physical strength and recovery. This holistic approach not only targets the physical aspects of cancer treatment but also the mental and emotional, offering a more comprehensive pre-operative care strategy.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

Research has shown that mindfulness meditation, which participants in this trial may receive, can boost the immune system and improve the quality of life for cancer patients. It may also help reduce anxiety and the fear of cancer recurrence. Meanwhile, studies have found that pre-surgery exercise programs, another treatment option in this trial, can aid bladder cancer patients in recovering better and enhancing their quality of life. Exercising before surgery might also improve heart and lung fitness and shorten hospital stays. This trial tests both mindfulness and exercise to prepare patients for bladder cancer surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to use the personal or study provided devices for monitoring and performing the exercise routines

You don't have any reasons that make high intensity exercise unsafe for you.

I am willing and able to follow the study rules and attend all required visits.

Exclusion Criteria

You have health conditions that make it unsafe for you to do aerobic exercise.

I have not experienced new chest pain or shortness of breath with activity.

My cancer has spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Habilitation

Participants engage in a home-based pre-operative exercise and mindfulness program to improve physical and psychological conditioning

4-8 weeks

Home-based program

Surgery

Participants undergo radical cystectomy for bladder cancer

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of post-operative complications and quality of life

30 days

Post-operative assessments

What Are the Treatments Tested in This Trial?

Interventions

• Pre-operative mindfulness meditation practice
• Pre-operative physical exercise

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

Preoperative pre-habilitation

Group II: Control Active Control 1 Intervention

Usual preoperative care prior to radical cystectomy

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Integrated Translational Health Research Institute of Virginia (iTHRIV)

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Prehabilitation, which includes exercise, nutritional support, and holistic care, is emerging as a crucial strategy to improve the physical and psychological well-being of patients with muscle invasive bladder cancer (MIBC) before radical cystectomy, as these patients often face multiple health challenges.

Individualized prehabilitation programs tailored to each patient's needs are recommended, highlighting the importance of a multidisciplinary approach to enhance postoperative outcomes and address the unmet supportive care needs of MIBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Exercise and Nutrition as Part of a Person-Centered Approach to Prehabilitation in Patients with Bladder Cancer. Nahon, I., Paterson, C., Sayner, A.[2021]

A pilot study involving 32 bladder cancer patients showed that a 2-week multimodal prehabilitation program improved physical capacity, as evidenced by a 9.2% increase in the six-minute walk test results from baseline to 6 weeks post-surgery.

Patients adhered to the nutritional component of the program at a higher rate (81%) compared to the exercise component (62%), indicating that while the program is feasible, enhancing adherence to physical exercises may be necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Multimodal Prehabilitation Program to Radical Cystectomy in a Comprehensive Cancer Center: A Pilot Study to Assess Feasibility and Outcomes. Jensen, BT., Jensen, JB., Love-Retinger, N., et al.[2022]

In a survey of 525 bladder cancer survivors, only 22.3% met public health exercise guidelines, highlighting a significant gap in physical activity among this group.

Those who met exercise guidelines reported significantly better quality of life scores across various domains, including functional well-being and sexual functioning, compared to those who were completely sedentary, suggesting that exercise may improve QoL for bladder cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between exercise and quality of life in bladder cancer survivors: a population-based study. Karvinen, KH., Courneya, KS., North, S., et al.[2015]

Radical cystectomy is the standard treatment for nonmetastatic, muscle invasive bladder cancer, but it has the highest mortality rate among uro-oncologic procedures, particularly affecting the growing number of elderly patients with comorbidities.

Prehabilitation before cystectomy aims to improve patients' physical condition through conditioning, strength training, and nutritional education, but current studies show mixed results regarding its effectiveness in reducing complications or mortality, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prehabilitation prior to radical cystectomy]. Giese, M., Butea-Bocu, M., Huber, J., et al.[2023]

A short-term exercise-based pre-habilitation program for patients with invasive bladder cancer awaiting radical cystectomy showed a high adherence rate of 66%, indicating that most patients were able to follow the recommended exercise regimen.

The intervention group experienced a significant improvement in muscle power of 18% at the time of surgery compared to the standard group, suggesting that pre-habilitation can enhance physical strength and potentially improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. Jensen, BT., Laustsen, S., Jensen, JB., et al.[2018]

A study involving 60 bladder cancer patients showed that those who participated in vigorous intensity aerobic interval exercise before surgery had significant improvements in cardiopulmonary fitness, as indicated by increased oxygen pulse, minute ventilation, and power output compared to the control group.

There were no adverse events reported during the exercise program, suggesting that this pre-operative exercise strategy is safe and could potentially enhance recovery after radical cystectomy, warranting further investigation in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vigorous intensity aerobic interval exercise in bladder cancer patients prior to radical cystectomy: a feasibility randomised controlled trial. Banerjee, S., Manley, K., Shaw, B., et al.[2019]

A 4-week prehabilitation program for cystectomy patients aged 60 and older was found to be feasible and safe, with 80.4% of participants successfully completing the program without any adverse events.

Participants showed significant improvements in strength, endurance, and quality of life, which were sustained 90 days after surgery, indicating the potential benefits of prehabilitation in enhancing recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Impact of a Presurgical Exercise Intervention Program (Prehabilitation) for Patients Undergoing Cystectomy for Bladder Cancer. Kaye, DR., Schafer, C., Thelen-Perry, S., et al.[2022]

A presurgical exercise program for bladder cancer patients is feasible and safe, with an 80% completion rate and no exercise-related adverse events reported during the study.

Participants showed significant improvements in physical function, including leg press strength and walking distance, as well as enhancements in quality of life, suggesting that exercise may help mitigate the negative impacts of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Feasibility of Presurgical Exercise in Bladder Cancer Patients Scheduled for Open Radical Cystectomy. Taaffe, DR., McCombie, SP., Galvão, DA., et al.[2023]

This study aims to determine if a multimodal prehabilitation program can reduce the risk of perioperative complications in 154 patients undergoing radical cystectomy for bladder cancer, compared to standard care.

The primary outcome will measure the occurrence of significant complications (grade ≥2) within 90 days post-surgery, with secondary outcomes assessing fitness, hospital stay length, quality of life, and other health markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. Akdemir, E., Sweegers, MG., Vrieling, A., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03767

Pre-habilitation with Mindfulness and Exercise for Patients ... This clinical trial tests the effect of a mindfulness and exercise program to improve the functional capability before surgery (pre-habilitation) in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147008/

Improving cancer patients' prognosis by incorporating ... Results showed that the experimental group had significant improvements in immune function, tumor markers, depression severity, quality of life, cancer-related ...

3. urotoday.com urotoday.com/conference-highlights/suo-2024/suo-2024-bladder-cancer/156665-suo-2024-a-personalized-and-pragmatic-approach-to-p-rehabilitation-for-patients-with-bladder-cancer.html

SUO 2024: A Personalized and Pragmatic Approach to (P) ... Meditation and mindfulness practices can help enhance mental clarity and focus, while yoga and chair yoga provide gentle physical activity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04049214

Study Details | NCT04049214 | Perioperative Mindfulness ... The purpose of this study is to determine if a regular meditation and breath work practice started before surgery and continued through post-surgical recovery ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11535076/

Effects of Mindfulness Meditation on Patient Experience ... Mindfulness has also shown promise in the field of urology, where it may reduce anxiety, avoidance, and fear of cancer recurrence in patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6371675/

A Systematic Review: Mindfulness Intervention for Cancer ... Study outcomes include improved pain severity, anxiety, stress, depression, and QoL. However, most studies reviewed were conducted in the United States and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9246505/

Mindfulness for patients undergoing surgery: a cost-effective ... Unaddressed preoperative anxiety and depression have been linked to more than just pain scores, affecting postoperative nausea, agitation, and even increased ...

8. withpower.com withpower.com/trial/phase-pain-postoperative-2022-8c0f1

Mindfulness Training for Postoperative Pain This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and ...