Lifestyle Intervention for Bladder Cancer
(BOOST Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Utah
Disqualifiers: Special dietary requirements, others
Stay on Your Current Meds
No Placebo Group
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.
12345Is 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.
13467How 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.
89101112Eligibility 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
I am 18 years old or older.
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
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: BOOST Box InterventionExperimental Treatment1 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 CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Huntsman Cancer InstituteSalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
Lifestyle factors and health-related quality of life in bladder cancer survivors: a systematic review. [2018]Diet, physical activity, and smoking cessation are modifiable lifestyle factors that have been shown to improve health-related quality of life (HRQOL) in many cancer survivors. Our objective was to systematically review the literature on the associations between lifestyle factors, namely diet, physical activity, smoking status, and HRQOL in bladder cancer survivors.
Lifestyle and nutritional modifiable factors in the prevention and treatment of bladder cancer. [2020]Bladder cancer is one of the top 5 most common cancers diagnosed in the U.S. It is also one of the most expensive cancers to treat through the life course given its high rate of recurrence. While cigarette smoking and occupational exposures have been firmly established as risk factors, it is less certain whether modifiable lifestyle factors such as diet and physical activity play roles in bladder cancer etiology and prognosis. This literature review based on a PubMed search summarizes the research to date on key dietary factors, types of physical activity, and smoking in relation to bladder cancer incidence, and discusses the potential public health implications for formalized smoking cessation programs among recently diagnosed patients. Overall, population-based research in bladder cancer is growing, and will be a key platform to inform patients diagnosed and living with bladder cancer, as well as their treating clinicians, how lifestyle changes can lead to the best outcomes possible.
Exercise Decreases and Smoking Increases Bladder Cancer Mortality. [2018]The aim of this study was to investigate modifiable lifestyle factors of smoking, exercise, and obesity with bladder cancer mortality.
Glycemic impact of a diet and lifestyle intervention on diabetics and prediabetics during treatment for non-muscle invasive bladder cancer. [2022]Introduction: Patients with Type II Diabetes Mellitus (DM2) have increased risk of recurrence and progression of non-muscle invasive bladder cancer (NMIBC). Glucose control through lifestyle intervention is an uninvestigated, attractive strategy to decrease risk of cancer recurrence. We test the feasibility of a diet and exercise program and its glycemic impact in patients with DM2 and NMIBC.Materials/methods: Five participants with NMIBC and pre-diabetes or DM2 were recruited for a pilot, prospective clinical trial. Each participant received dietary counseling for 16 sessions during clinical visits. The intervention included a carbohydrate-restricted (CR) diet (<130 grams per day), 30 min, walking 5×/wk, and 5000 steps daily. Diet compliance was measured with 24-hour diet recall. Exercise was monitored with accelerometer and self-report.Results: Five participants enrolled and two participants completed the 12-month intervention. Adherence was 60% to CR diet and 84% to exercise goals. Participants reduced carbohydrate consumption by 44%. Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring.Conclusions: Adherence to a CR diet and exercise goals is feasible in patients with NMIBC and DM2 and also leads improved glucose control. A phase-II trial on bladder cancer-specific outcomes is warranted.
Associations between exercise and quality of life in bladder cancer survivors: a population-based study. [2015]Exercise has been shown to improve quality of life (QoL) in some cancer survivor groups, but it is unknown if the unique QoL issues faced by bladder cancer survivors are also amenable to an exercise intervention. This study provides the first data examining the association between exercise and QoL in bladder cancer survivors.
Longitudinal associations of adherence to lifestyle recommendations and health-related quality of life in patients with non-muscle invasive bladder cancer. [2023]Although the role of lifestyle in health-related quality of life (HRQoL) outcomes has been increasingly recognized for various types of cancer, evidence in patients with non-muscle invasive bladder cancer (NMIBC) is very limited. We aimed to evaluate the longitudinal association between adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) lifestyle recommendations and HRQoL in patients with NMIBC. This study included 1029 patients with NMIBC recruited between May 2014 and April 2017 from the Dutch multi-centre prospective cohort study UroLife. Lifestyle and HRQoL data were collected at 6 weeks (baseline), 3 months and 15 months after diagnosis. Information on body mass index (BMI), physical activity, diet and alcohol was used to compute the standardized WCRF/AICR adherence score (0-7). HRQoL outcomes were evaluated by the EORTC QLQ-C30. Linear mixed models were used to assess longitudinal confounder-adjusted associations between the WCRF/AICR adherence score and HRQoL outcomes. Adherence to each additional WCRF/AICR recommendation was associated with better global quality of life, physical, role and social functioning, and less fatigue. We found stronger inter-individual than intra-individual associations, suggesting that associations were mainly driven by between-subject differences. Higher adherence to the BMI, physical activity and dietary recommendations was associated with better scores for most HRQoL outcomes, while adherence to the alcohol recommendation (ie, non-consumption) was associated with worse HRQoL. Following the WCRF/AICR lifestyle recommendations may improve HRQoL in patients with NMIBC. Intervention studies are needed to establish whether the association between lifestyle and HRQoL is causal.
Prevention of bladder cancer incidence and recurrence: nutrition and lifestyle. [2018]We review the influence of nutrition and lifestyle on bladder cancer incidence and recurrence and summarize food items, diets and lifestyle practices that physicians may wish to prioritize for discussion with their patients.
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]In this study, we examined predictors of exercise adherence, contamination and dropout in lung and oesophageal cancer patients who participated in two randomised controlled trials.
Experiences of using a supported digital intervention for cancer survivors in primary care: a qualitative process evaluation. [2023]Increasing healthy behaviours (e.g. physical activity) can improve cancer survivors' quality of life. Renewed is a digital intervention developed to provide behaviour change advice with brief healthcare practitioner support. A three-arm randomised controlled trial (Renewed, Renewed with support or a control condition) suggested that prostate cancer survivors in the supported arm had slightly greater estimates of improvements in quality of life compared to other cancer survivors. This study explored participants' experiences using Renewed to understand how it might have worked and why it might have provided greater benefit for prostate cancer survivors and those in the supported arm.
Development and validation of a lifestyle-based model for colorectal cancer risk prediction: the LiFeCRC score. [2023]Nutrition and lifestyle have been long established as risk factors for colorectal cancer (CRC). Modifiable lifestyle behaviours bear potential to minimize long-term CRC risk; however, translation of lifestyle information into individualized CRC risk assessment has not been implemented. Lifestyle-based risk models may aid the identification of high-risk individuals, guide referral to screening and motivate behaviour change. We therefore developed and validated a lifestyle-based CRC risk prediction algorithm in an asymptomatic European population.
Time course of risk factors in cancer etiology and progression. [2022]Patients with cancer increasingly ask what they can do to change their lifestyles and improve outcomes. Risk factors for onset of cancer may differ substantially from those that modify survival with implications for counseling. This review focuses on recent data derived from population-based studies of causes of cancer and of patients with cancer to contrast risk factors for etiology with those that impact survival. For different cancer sites, the level of information to inform the timing of lifestyle exposures and risk of disease onset or progression after diagnosis is often limited. For breast cancer, timing of some exposures, such as radiation, is particularly important. For other exposures, such as physical activity, higher levels may prevent onset and also improve survival. For colon cancer, study of precursor polyps has provided additional insight to timing. Extensive data indicate that physical activity reduces risk of colon cancer, and more limited data suggest that exposure after diagnosis improves survival. Dietary factors including folate and calcium may also reduce risk of onset. More limited data on prostate cancer point to obesity increasing risk of aggressive or advanced disease. Timing of change in lifestyle for change in risk of onset and for survival is important but understudied among patients with cancer. Counseling patients with cancer to increase physical activity and avoid weight gain may improve outcomes. Advice to family members on lifestyle may become increasingly important for breast and other cancers where family history is a strong risk factor.
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]Label="Objective" NlmCategory="UNASSIGNED">To facilitate replication and future intervention design of web-based multibehavior lifestyle interventions, we describe the rationale, development, and content of the AiM, Plan, and act on LIFestYles (AMPLIFY) Survivor Health intervention which provides healthy eating and exercise behavior change support for older cancer survivors. The intervention promotes weight loss, improvements in diet quality, and meeting exercise recommendations.