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NCT06002269 · ClinicalTrials.gov registry record · NA
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients
A NA study of Bladder Cancer and Cystectomy, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT06002269 is a NA study of Bladder Cancer and Cystectomy that has completed, run by University of Utah. The registered enrollment target is 8 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06002269, a NA study of Bladder Cancer and Cystectomy, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Dietary and Exercise Intervention
Study Locations (1)
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-07-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06002269
The ClinicalTrials.gov registry entry for NCT06002269 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Dietary and Exercise Intervention is the first listed.
NCT06002269 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT06002269 about?
NCT06002269 is a clinical study titled "A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients". 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-o...
What is the current status of trial NCT06002269?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2024-06-04. Estimated completion is 2025-07-08.
What conditions does trial NCT06002269 study?
This clinical trial studies the following conditions: Bladder Cancer, Cystectomy, Chemotherapy.
What interventions are being tested in trial NCT06002269?
The interventions under investigation include: Dietary and Exercise Intervention (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06002269?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06002269 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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