Patient-Centered Surgical Prehabilitation (Prehab)

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Cystectomy
• Intervention / Treatment: Other: Exercise Training; Dietary supplement: Nutritional Intervention

Detailed Description

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:

• Participant Interview (If one of the first ten participants)
• Exercise Testing
• Exercise Training
• Nutritional Support
• Clinical Assessment of Nutritional Status

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patents must be candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach.
2. Patients between the ages 18 and 85 years
3. American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
4. Ileal conduit or ileal neobladder urinary diversion
5. Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent

Exclusion Criteria:

1. Scheduled for a partial cystectomy
2. Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
3. More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
4. The presence of metastatic cancer
5. Be undergoing treatment for another type of cancer concurrently
6. Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
7. Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.)
8. Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
9. Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
10. Using illicit drugs or abusing alcohol
11. History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures
12. Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
13. Patients with severe hepatic impairment as defined by Child-Pugh Class C. Patients with Child-Pugh Class A-B hepatic impairment are eligible for the study.
14. A history of heart failure.
15. Patients with end-stage renal disease as defined by GFR <15.
16. Patients with heart failure.
17. Patients with complete gastrointestinal obstruction.
18. Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds.
19. Non-English-speaking patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard treatment Plan; This is the main arm of the study in which all 25 anticipated participants will be enrolled into.	Other: Exercise Training; Virtually supervised exercise training for four weeks prior to cystectomy; Dietary supplement: Nutritional Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): December 27, 2026
• Study Completion (Anticipated): December 25, 2027

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 22-329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No