Actively Recruiting
Patient-Centered Surgical Prehabilitation for Bladder Cancer Patients Undergoing Cystectomy
Led by Dana-Farber Cancer Institute · Updated on 2023-03-22
25
Participants Needed
2
Research Sites
51 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
A
Abbott Nutrition
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a prehabilitation program designed to prepare the body physically and nutritionally before cystectomy, which is the surgical removal of the bladder. This investigational study aims to determine the effectiveness of combining specific interventions to improve recovery after cystectomy and to identify the best combination of these prehabilitation interventions for future research. The study is sponsored by the Dana-Farber Cancer Institute and focuses on adults scheduled for bladder removal surgery. The program includes five key interventions: participant interview (for some early enrollees), exercise testing, exercise training, nutritional support, and clinical assessment of nutritional status. Specifically, participants will undergo virtually supervised exercise training for four weeks before surgery and receive liquid nutritional supplements (Ensure shakes) for two weeks before and one week after surgery. All participants will be enrolled in this single treatment arm. During the study, participants will be monitored for outcomes such as total days hospitalized within 30 days post-surgery, length of hospital stay, number and type of complications, discharge disposition, and readmissions. Assessments include interviews, physical and nutritional evaluations, and adherence to the exercise and nutritional plans. The study will track these outcomes for up to 60 months to evaluate long-term effects of the prehabilitation program.
CONDITIONS
Brief Title
Patient-Centered Surgical Prehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach
- Age between 18 and 85 years
- American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
- Undergoing ileal conduit or ileal neobladder urinary diversion
- Able to understand study procedures, agree to participate, and provide informed consent
You will not qualify if you...
- Scheduled for a partial cystectomy
- Previous total colectomy, gastrectomy, gastric bypass, or functional colostomy or ileostomy
- More than three doses of opioids within 7 days before surgery
- Presence of metastatic cancer
- Receiving treatment for another type of cancer concurrently
- Chemotherapy for bladder cancer within 1 month of surgery (prior neoadjuvant chemotherapy allowed)
- Pregnant, lactating, or of childbearing potential without accepted birth control use
- Participation in another investigational drug or device study within 30 days before surgery
- Clinically significant lab abnormalities that would cancel surgery
- Illicit drug use or alcohol abuse
- History of surgeries, illnesses, or behaviors that could affect study results or increase risk
- Severe dementia impacting daily functioning
- Severe hepatic impairment (Child-Pugh Class C)
- History of heart failure
- End-stage renal disease with GFR <15
- Complete gastrointestinal obstruction
- Presence of gastrostomy or jejunostomy tubes or need for enteral tube feeds
- Non-English-speaking patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo a set of prehabilitation interventions including virtually supervised exercise training for four weeks and nutritional support with liquid Ensure supplemental shakes for 2 weeks prior to cystectomy.
Weekly visits for up to 4 weeks
Duration - 1 week
Participants undergo cystectomy surgery followed by immediate post-operative nutritional support with liquid Ensure supplemental shakes for 1 week.
1 visit for surgery and approximately 1 post-operative visit
Duration - Up to 60 months
Participants are monitored for recovery outcomes including hospitalization days, complications, and readmissions for up to 60 months after surgery.
Follow-up visits as scheduled for up to 60 months
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Matthew Mossanen, MD, MPH
N
Nnamdi Onochie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here