Patient-Centered Surgical Prehabilitation

NCT05715684 | Recruiting

• 1 other identifier: 22-329
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bladder Cancer; Cystectomy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Standard treatment Plan

OTHER

This is the main arm of the study in which all 25 anticipated participants will be enrolled into.

Other: Exercise Training; Dietary Supplement: Nutritional Intervention

Interventions

Exercise Training OTHER

Virtually supervised exercise training for four weeks prior to cystectomy

Standard treatment Plan

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

Standard treatment Plan

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Scheduled for a partial cystectomy
• Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
• More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
• The presence of metastatic cancer
• Be undergoing treatment for another type of cancer concurrently
• Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
• 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.)
• 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
• Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
• Using illicit drugs or abusing alcohol
• 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
• Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
• 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.
• A history of heart failure.
• Patients with end-stage renal disease as defined by GFR \<15.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Abbott Nutrition: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Matthew Mossanen, MD, MPH

CONTACT

617-732-6384; mmossanen@bwh.harvard.edu

Nnamdi Onochie

CONTACT

6175258753; nnamdi_onochie@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Surgeon

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): December 25, 2027
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)