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Brief Title: Patient-Centered Surgical Prehabilitation

Patient-Centered Surgical Prehabilitation

INTRODUCTION

  • Org Study ID: 22-329
  • Secondary ID: N/A
  • NCT ID: NCT05715684
  • Sponsor: Dana-Farber Cancer Institute

DESCRIPTION

     The prehabilitation study is a multidisciplinary program aimed at preparing cystectomy patients nutritionally and physically for the cystectomy surgery. Through the prehabilitation program cystectomy patients will be enrolled 4 weeks prior to their scheduled cystectomy date. Patients will undergo an exercise test to assess their baseline fitness status prior to the cystectomy procedure. Following the exercise test participants will receive exercise training meant to physically prepare patients to endure the cystectomy surgery. This exercise training will be supervised by exercise physiologist who will guide participants through each exercise. After the initial study visit where the exercises testing will occur, exercise training will occur virtually.

      As part of the nutritional aspect of the study participants will be offered consultation with a registered dietician who will provide specific recommendations for patients about to undergo cystectomy that emphasizes the importance of having a well-balanced diet. Patients will also receive Ensure supplemental shakes both before and after their cystectomy Surgery. Patient will also be asked to fill out a clinical assessment of nutritional status. This will help us determine each patients baseline nutritional status. Patients will receive another clinical assessment of nutritional status post-surgery, this will help us determine if there has been any change in nutritional status as a result of the prehabilitation program. We are aiming to accrue 25 patients with bladder cancer who have been scheduled for a cystectomy surgery.

We will also randomly select 10 participants who have completed the prehabilitation study to conduct face-to-face interviews in person or over zoom. We will also obtain quantitative data by having the participants completes 5 different surveys/ questionnaires. The 5 different surveys and questionnaires will help us determine specific data about patient experiences and facilitators and barriers to participation in the prehabilitation study.

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

  • Overall Status
    Recruiting
  • Start Date
    March 1, 2023
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer
  • Cystectomy

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Matthew Mossanen, MD, MPH, Nnamdi Onochie

Phone: 617-732-6384, 6175258753

Email: mmossanen@bwh.harvard.edu, nnamdi_onochie@dfci.harvard.edu

LOCATION

Facility Status Contact
Facility: Brigham and Women's Hospital
Boston, Massachusetts 02115
United States 		Status: Recruiting Contact: Contact
Matthew Mossanen, MD
617-732-6384
mmossanen@bwh.harvard.edu

Principal Investigator
Matthew Mossanen, MD
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States 		Status: Recruiting Contact: Contact
Matthew Mossanen, MD
617-732-6384
mmossanen@bwh.harvard.edu

Principal Investigator
Matthew Mossanen, MD

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