search
Back to results

Patient-Centered Surgical Prehabilitation (Prehab)

Primary Purpose

Bladder Cancer, Cystectomy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Nutritional Intervention
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. Patients with heart failure. Patients with complete gastrointestinal obstruction. Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds. Non-English-speaking patients

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard treatment Plan

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Length of stay
This is the total length of stay in days after bladder removal surgery
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
Discharge disposition
This is the disposition of the patient at discharge or when the patient is released from the hospital.
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.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2023
Last Updated
March 20, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Abbott Nutrition
search

1. Study Identification

Unique Protocol Identification Number
NCT05715684
Brief Title
Patient-Centered Surgical Prehabilitation
Acronym
Prehab
Official Title
Patient-Centered Surgical Prehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 27, 2026 (Anticipated)
Study Completion Date
December 25, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Abbott Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Cystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment Plan
Arm Type
Other
Arm Description
This is the main arm of the study in which all 25 anticipated participants will be enrolled into.
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
Virtually supervised exercise training for four weeks prior to cystectomy
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Total days hospitalized within 30-days of surgery
Description
This is the total number of days within 30 days after bladder removal surgery, that a patient is hospitalized.
Time Frame
60 months
Title
Length of stay
Description
This is the total length of stay in days after bladder removal surgery
Time Frame
60 months
Title
Number and type of minor and major complications
Description
This is the number and types of major and minor complications which occur post bladder removal surgery
Time Frame
60 months
Title
Discharge disposition
Description
This is the disposition of the patient at discharge or when the patient is released from the hospital.
Time Frame
60 months
Title
Readmissions
Description
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.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Patients with heart failure. Patients with complete gastrointestinal obstruction. Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds. Non-English-speaking patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Mossanen, MD, MPH
Phone
617-732-6384
Email
mmossanen@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nnamdi Onochie
Phone
6175258753
Email
nnamdi_onochie@dfci.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD
Phone
617-732-6384
Email
mmossanen@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD
Phone
617-732-6384
Email
mmossanen@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Patient-Centered Surgical Prehabilitation

We'll reach out to this number within 24 hrs