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Behavioural Intervention

Lifestyle Intervention for Bladder Cancer (BOOST Trial)

N/A

Recruiting

Led By Mary C Playdon, PhD, MPH

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or without neo-adjuvant therapy and treated with surgery at the Huntsman Cancer Institute

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the 6-month follow-up survey

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new diet and exercise program called "The Boost Box" for urinary bladder cancer patients undergoing surgery. The study will assess the feasibility and effects of the intervention on complications, nutrition

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a dietary and exercise intervention rather than medication or invasive treatment, side effects may include typical reactions to changes in diet or physical activity such as muscle soreness from exercise or gastrointestinal discomfort from new foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the 6-month follow-up survey

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the 6-month follow-up survey

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the 6-month follow-up survey for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of BOOST Box Intervention

Feasibility of BOOST Box Intervention

Secondary study objectives

Body weight

Malnutrition assessment

Quality of Life (Physical, social, emotional, functional well-being, and a bladder cancer subscale)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 1Eligibility criteria met