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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Exercise + Mindfulness for Bladder Cancer?

Research shows that exercise-based pre-habilitation, which includes physical exercises before surgery, is feasible and can improve physical fitness in bladder cancer patients awaiting surgery. This approach aims to enhance patients' physical and psychological well-being, potentially leading to better recovery after surgery. ^{1 2 3 4 5}

Is exercise and mindfulness prehabilitation safe for bladder cancer patients?

The studies suggest that exercise-based prehabilitation, including vigorous aerobic exercise, is generally feasible and aims to improve physical and psychological well-being before surgery, which can help reduce complications and improve recovery. However, specific safety data for mindfulness practices in this context is not detailed in the available research. ^{1 2 4 5 6}

How is the Exercise + Mindfulness treatment for bladder cancer different from other treatments?

This treatment is unique because it combines physical exercise and mindfulness meditation to improve patients' physical and psychological well-being before surgery, aiming to enhance recovery and reduce complications, unlike traditional treatments that focus solely on medical or surgical interventions. ^{1 4 7 8 9}

Eligibility Criteria

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.

My cancer has spread to distant parts of my body.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Feasibility of Presurgical Exercise in Bladder Cancer Patients Scheduled for Open Radical Cystectomy. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Prehabilitation prior to radical cystectomy]. [2023]

4. United States 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. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Vigorous intensity aerobic interval exercise in bladder cancer patients prior to radical cystectomy: a feasibility randomised controlled trial. [2019]

6. England 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. [2023]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Associations between exercise and quality of life in bladder cancer survivors: a population-based study. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

The Feasibility and Impact of a Presurgical Exercise Intervention Program (Prehabilitation) for Patients Undergoing Cystectomy for Bladder Cancer. [2022]