Lifestyle Intervention for Bladder Cancer

(BOOST Trial)

Overseen By Mary C Playdon, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Special dietary requirements, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test a randomized, controlled diet and physical activity intervention designed to be simple and address barriers to participation in lifestyle intervention among 16 urinary bladder cancer patients. Aim 1 is to test the feasibility and acceptability of a novel, peri-operative lifestyle intervention, "The Boost Box", among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy. Aim 2 is to measure the feasibility of collecting data on the intervention effects on complication rate, nutritional status, weight loss, and quality of life post-surgery among bladder cancer patients receiving cystectomy ± neoadjuvant therapy. Secondarily, we will determine the magnitude of association between study group and outcomes to inform power calculations in a future, well-powered trial. Participants will: * attend two dietetic consultations at baseline and post-surgical recovery where nutritional status will be evaluated with patient-generated subjective global assessment (PG-SGA) * complete baseline questionnaires (TCC, FACT-BI-Cys, Short 2012, FAACT, Godin) * receive weekly BOOST boxes * complete pre-surgery weekly BOOST check ins * complete post-surgery weekly BOOST check ins * complete an ASA food recall pre and post-surgery * complete an exercise familiarization consult * record weekly resistance and aerobic exercise performed at home * complete a 6 month follow-up questionnaire * receive compensation Researchers will compare to a Usual Care group to determine differences that could be attributed to the BOOST Box intervention.

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 Dietary and Exercise Intervention, Lifestyle Intervention, Dietary and Exercise Intervention, The Boost Box for bladder cancer?

Research shows that lifestyle changes like diet and exercise can improve the quality of life for bladder cancer survivors. Exercise has been linked to better quality of life, and dietary changes can help manage blood sugar levels, which is important for patients with diabetes and bladder cancer. ^{1 2 3 4 5}

Is the lifestyle intervention for bladder cancer safe for humans?

The lifestyle intervention, which includes diet and exercise, has been shown to improve health-related quality of life in bladder cancer patients and is feasible for those with diabetes, suggesting it is generally safe for humans. ^{1 3 4 6 7}

How does the Lifestyle Intervention for Bladder Cancer differ from other treatments?

The Lifestyle Intervention for Bladder Cancer is unique because it focuses on dietary and exercise changes to improve health, rather than using medication or surgery. This approach is similar to interventions used for other cancers, where increasing physical activity and improving diet have been shown to enhance quality of life and potentially improve survival. ^{8 9 10 11 12}

Research Team

Mary C Playdon, PhD, MPH

Principal Investigator

University of Utah NUIP Department and Huntsman Cancer Institute

Eligibility Criteria

This trial is for adults over 18 diagnosed with bladder cancer who are set to undergo cystectomy, with or without neo-adjuvant therapy. Participants need reliable internet access and will be mostly male and white based on projected demographics. Children, pregnant women, and those without web access cannot join.

Inclusion Criteria

I have been diagnosed with bladder cancer and am scheduled for surgery at the Huntsman Cancer Institute.

Have reliable, consistent access to the internet for study procedures

Exclusion Criteria

Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet)

Unable to provide informed consent or read, write, or fill in questionnaires in English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete baseline questionnaires and dietetic consultations

1-2 weeks

2 visits (in-person)

Pre-Surgery Intervention

Participants receive Boost Box deliveries and exercise interventions

3-6 weeks

Weekly check-ins (virtual)

Post-Surgery Intervention

Participants continue Boost Box deliveries and exercise interventions

6 weeks

Weekly check-ins (virtual)

Follow-up

Participants complete a 6-month follow-up questionnaire

6 months

1 visit (virtual)

Treatment Details

Interventions

• Dietary and Exercise Intervention

Trial Overview The study tests a 'Boost Box' lifestyle intervention against usual care in bladder cancer patients undergoing surgery. It includes dietetic consultations, nutritional assessments, exercise guidance, weekly check-ins, food recalls pre/post-surgery, home exercises recording, and follow-up questionnaires.

Participant Groups

Group I: BOOST Box Intervention Experimental Treatment 1 Intervention

Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), exercise prescription, compensation. Pre-Surgery: Dietitian consultation, at least 3-weeks and up to 6-weeks of Boost Box deliveries and check-ins (nutritional intervention), up to 6 weeks of exercise intervention and logs, ASA Food Record (x2), compensation Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), 6 weeks of Boost Box deliveries and check-ins (nutritional intervention), 6 weeks of exercise intervention and logs, weekly hunger check-in, ASA Food Record (x2), Dietitian consultation, compensation. Follow-up (estimated 6 months after baseline) : 6-month questionnaire, compensation. Compensation total: up to $100 via electronic gift card.

Group II: Usual Care Active Control 1 Intervention

Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), compensation. Pre-Surgery: Dietitian consultation, ASA Food Record (x2), compensation. Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), Dietitian consultation, ASA Food Record (x2), compensation. Follow-up (estimated 6 months after baseline): 6-month questionnaire, compensation. Compensation total: up to $100 via electronic gift card.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

A systematic review of 9 studies involving 1288 bladder cancer survivors found some evidence that physical activity positively impacts health-related quality of life (HRQOL), but the evidence is limited.

There is insufficient evidence to conclude the effects of diet, specifically fruit and vegetable consumption, or smoking cessation on HRQOL in bladder cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle factors and health-related quality of life in bladder cancer survivors: a systematic review. Gopalakrishna, A., Longo, TA., Fantony, JJ., et al.[2018]

Bladder cancer is one of the most common and costly cancers to treat in the U.S., with a high recurrence rate, highlighting the need for effective management strategies.

The review emphasizes the importance of understanding the role of lifestyle factors, such as diet and physical activity, in bladder cancer incidence and prognosis, suggesting that lifestyle changes could improve outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle and nutritional modifiable factors in the prevention and treatment of bladder cancer. Kwan, ML., Garren, B., Nielsen, ME., et al.[2020]

In a study of 222,163 participants, those who engaged in any form of exercise were found to be 47% less likely to die from bladder cancer compared to those who did not exercise, highlighting the protective effect of physical activity.

Current smokers had a significantly higher risk of bladder cancer mortality, being 4 times more likely to die from the disease compared to never-smokers, while former smokers were 3 times more likely, indicating the importance of smoking cessation in reducing bladder cancer deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Decreases and Smoking Increases Bladder Cancer Mortality. Liss, MA., White, M., Natarajan, L., et al.[2018]

A pilot study involving 5 participants with non-muscle invasive bladder cancer and Type II Diabetes showed that a carbohydrate-restricted diet and exercise program is feasible, with 60% adherence to the diet and 84% to exercise goals over 12 months.

Participants experienced significant improvements in glucose control, including reductions in fasting blood glucose and HbA1c levels, suggesting that lifestyle interventions may help manage diabetes and potentially reduce cancer recurrence risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic impact of a diet and lifestyle intervention on diabetics and prediabetics during treatment for non-muscle invasive bladder cancer. Chestnut, C., Smelser, W., Dum, T., 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]

In a study of 1029 patients with non-muscle invasive bladder cancer (NMIBC), adherence to the 2018 WCRF/AICR lifestyle recommendations was linked to improved health-related quality of life (HRQoL), including better global quality of life and reduced fatigue.

Specifically, higher adherence to recommendations regarding body mass index, physical activity, and diet correlated with better HRQoL outcomes, while non-consumption of alcohol was associated with worse HRQoL, indicating the importance of lifestyle choices in managing health in NMIBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal associations of adherence to lifestyle recommendations and health-related quality of life in patients with non-muscle invasive bladder cancer. Vidra, N., Beeren, I., van Zutphen, M., et al.[2023]

Certain dietary factors, such as the consumption of meat, fruits, and vegetables, are associated with bladder cancer incidence, but no specific diet has been proven to reduce the risk of developing the disease.

While smoking cessation is the only lifestyle change with strong evidence for reducing bladder cancer risk, factors like stress, anxiety, and sleep deprivation may increase risk, and exercise may help lower mortality rates in bladder cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of bladder cancer incidence and recurrence: nutrition and lifestyle. Fankhauser, CD., Mostafid, H.[2018]

In a study of 188 lung and oesophageal cancer patients participating in a 12-week walking program, pre-intervention exercise habits and baseline depression levels were significant predictors of exercise adherence, explaining 16.7% of the variance in adherence rates.

For patients in the control group, higher levels of pre-intervention moderate and vigorous physical activity increased the likelihood of contamination, while lower levels of mild physical activity were associated with higher dropout rates in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adherence, contamination and dropout in home-based walking by lung and oesophageal cancer patients from two randomised control trials: An exploratory study. Chen, HM., Lee, MC., Wu, YC., et al.[2022]

The Renewed digital intervention showed potential in promoting healthy behavior changes among cancer survivors, particularly benefiting prostate cancer survivors who reported less social support compared to those with other cancers.

Even participants who used Renewed only modestly experienced positive behavior changes, suggesting that the intervention can be effective even with limited engagement, highlighting the importance of targeting individuals with low social support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of using a supported digital intervention for cancer survivors in primary care: a qualitative process evaluation. Smith, J., Essery, R., Yardley, L., et al.[2023]

The LiFeCRC score, developed from data of 255,482 participants in the EPIC study, effectively predicts colorectal cancer risk by incorporating lifestyle factors such as diet, physical activity, and smoking, alongside age.

The model demonstrated strong accuracy in identifying high-risk individuals, particularly benefiting younger adults under 45, and could be a valuable tool for motivating lifestyle changes to reduce colorectal cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a lifestyle-based model for colorectal cancer risk prediction: the LiFeCRC score. Aleksandrova, K., Reichmann, R., Kaaks, R., et al.[2023]

Physical activity is beneficial for both preventing the onset of colon cancer and improving survival rates after diagnosis, highlighting the importance of lifestyle changes for cancer patients.

Timing of lifestyle changes, such as increasing physical activity and managing weight, is crucial for improving cancer outcomes, but this area remains under-researched, indicating a need for better counseling for patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course of risk factors in cancer etiology and progression. Wei, EK., Wolin, KY., Colditz, GA.[2022]

The AMPLIFY intervention is a web-based program designed to support healthy eating and exercise for older cancer survivors, promoting weight loss and improved diet quality over a structured 48-week period.

Developed using social cognitive theory and incorporating feedback from cancer survivors and experts, the intervention includes interactive e-learning, progress tracking, and social support features, making it a comprehensive resource for behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. Rogers, LQ., Pekmezi, D., Schoenberger-Godwin, YM., et al.[2023]

References

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

Lifestyle factors and health-related quality of life in bladder cancer survivors: a systematic review. [2018]

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

Lifestyle and nutritional modifiable factors in the prevention and treatment of bladder cancer. [2020]

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

Exercise Decreases and Smoking Increases Bladder Cancer Mortality. [2018]

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

Glycemic impact of a diet and lifestyle intervention on diabetics and prediabetics during treatment for non-muscle invasive bladder cancer. [2022]

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

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

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

Longitudinal associations of adherence to lifestyle recommendations and health-related quality of life in patients with non-muscle invasive bladder cancer. [2023]

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

Prevention of bladder cancer incidence and recurrence: nutrition and lifestyle. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Predictors of adherence, contamination and dropout in home-based walking by lung and oesophageal cancer patients from two randomised control trials: An exploratory study. [2022]

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

Experiences of using a supported digital intervention for cancer survivors in primary care: a qualitative process evaluation. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Development and validation of a lifestyle-based model for colorectal cancer risk prediction: the LiFeCRC score. [2023]

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

Time course of risk factors in cancer etiology and progression. [2022]

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

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. [2023]