Clinical trial · Interventional
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Cystectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary and Exercise Intervention | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BOOST Box Intervention
- description
- 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.
- interventionNames
- Combination Product: Dietary and Exercise Intervention
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients 18 years or older. 2. Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or without neo-adjuvant therapy; Treated with surgery at the Huntsman Cancer Institute 3. Have reliable, consistence access to the internet for study procedures Inclusion of Individuals across the Lifespan: The proposed trial will enroll 20 adults who have been diagnosed with bladder cancer. The age range of participants to be recruited is 18 years or older. Bladder cancer is generally a disease of older age and is exceedingly rare in children. According to the American Cancer Society, average age at diagnosis is 73.1 Therefore, we are unable to include children in this trial. Inclusion of Women, Minorities, and Children: It is anticipated that 20% will be female; 80% male. Racial distribution is projected to be as follows: 97% white, 1% Native Hawaiian or Pacific Islander; 1% American Indian/ Alaska Native; 1% Asian; \<1% Black. Approximately 96% will be Non-Hispanic. Exclusion Criteria: 1. Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet). 2. Unable to provide informed consent or read, write, or fill in questionnaires in English
References
Publications (42)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. PMID 31912902
- BACKGROUNDTobert CM, Hamilton-Reeves JM, Norian LA, Hung C, Brooks NA, Holzbeierlein JM, Downs TM, Robertson DP, Grossman R, Nepple KG. Emerging Impact of Malnutrition on Surgical Patients: Literature Review and Potential Implications for Cystectomy in Bladder Cancer. J Urol. 2017 Sep;198(3):511-519. doi: 10.1016/j.juro.2017.01.087. Epub 2017 Mar 9. PMID 28286066
- BACKGROUNDGregg JR, Cookson MS, Phillips S, Salem S, Chang SS, Clark PE, Davis R, Stimson CJ Jr, Aghazadeh M, Smith JA Jr, Barocas DA. Effect of preoperative nutritional deficiency on mortality after radical cystectomy for bladder cancer. J Urol. 2011 Jan;185(1):90-6. doi: 10.1016/j.juro.2010.09.021. Epub 2010 Nov 12. PMID 21074802
- BACKGROUNDHansen TTD, Omland LH, von Heymann A, Johansen C, Clausen MB, Suetta C, Pappot H, Rafn BS. Development of Sarcopenia in Patients With Bladder Cancer: A Systematic Review. Semin Oncol Nurs. 2021 Feb;37(1):151108. doi: 10.1016/j.soncn.2020.151108. Epub 2021 Jan 8. PMID 33431235
- BACKGROUNDGrimberg DC, Shah A, Molinger J, Whittle J, Gupta RT, Wischmeyer PE, McDonald SR, Inman BA. Assessments of frailty in bladder cancer. Urol Oncol. 2020 Sep;38(9):698-705. doi: 10.1016/j.urolonc.2020.04.036. Epub 2020 May 22. PMID 32451229
- BACKGROUNDMaibom SL, Joensen UN, Poulsen AM, Kehlet H, Brasso K, Roder MA. Short-term morbidity and mortality following radical cystectomy: a systematic review. BMJ Open. 2021 Apr 14;11(4):e043266. doi: 10.1136/bmjopen-2020-043266. PMID 33853799
- BACKGROUNDJensen BT, Lauridsen SV, Jensen JB. Optimal Delivery of Follow-Up Care After Radical Cystectomy for Bladder Cancer. Res Rep Urol. 2020 Oct 14;12:471-486. doi: 10.2147/RRU.S270240. eCollection 2020.