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| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
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The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure.
This research study is testing the efficacy of the prehabilitation study which is a set of investigational interventions and also tries to define the most appropriate and effective set type of interventions to use for further studies. "Investigational" means that the intervention is being studied. In this research study, the investigators hope to learn whether or not this combination of prehabilitation interventions has an impact on the recoverability of participants who will undergo cystectomy or bladder removal surgery. The 5 interventions that make up the prehabilitation study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment Plan | Other | This is the main arm of the study in which all 25 anticipated participants will be enrolled into. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Other | Virtually supervised exercise training for four weeks prior to cystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total days hospitalized within 30-days of surgery | This is the total number of days within 30 days after bladder removal surgery, that a patient is hospitalized. | 60 months |
| Length of stay | This is the total length of stay in days after bladder removal surgery | 60 months |
| Number and type of minor and major complications | This is the number and types of major and minor complications which occur post bladder removal surgery | 60 months |
| Discharge disposition | This is the disposition of the patient at discharge or when the patient is released from the hospital. | 60 months |
| Readmissions | This is the number of times a patient that was discharged come back to the hospital for any issue related to their bladder removal surgery. | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Mossanen, MD, MPH | Contact | 617-732-6384 | mmossanen@bwh.harvard.edu | |
| Nnamdi Onochie | Contact | 6175258753 | nnamdi_onochie@dfci.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Nutritional Intervention | Dietary Supplement | Patients scheduled to undergo cystectomy will receive liquid Ensure supplemental shakes for 2 weeks prior to surgery and liquid Ensure supplemental shakes for 1 week postoperatively |
|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |