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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of BOOST Box Intervention
Feasibility of BOOST Box Intervention
Secondary outcome measures
Body weight
Malnutrition assessment
Quality of Life (Physical, social, emotional, functional well-being, and a bladder cancer subscale)
+1 more

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.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,177 Total Patients Enrolled
Mary C Playdon, PhD, MPHPrincipal InvestigatorUniversity of Utah NUIP Department and Huntsman Cancer Institute
~13 spots leftby May 2025
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