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NCT07638410
Prehabilitation in High-risk Oncologic Surgery
Conditions: Pancreatic Cancer, Colo-rectal Cancer, Gastric Cancer, Esophageal Cancer, Bladder Cancer, Ovarian Cancer, Abdominal Surgery Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: Fox Chase Cancer Center
Summary
The goal of this clinical study is to learn whether a prehabilitation program can improve recovery after major abdominal surgery in adults with cancer who are receiving treatment before surgery. Prehabilitation is supportive care given before surgery to help patients prepare physically, nutritionally, and emotionally.
The main questions this study aims to answer are:
1. Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery?
2. Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery?
3. Does prehabilitation affect the length of the hospital stay after surgery, the time it takes to start additional cancer treatment after surgery, or the ability to complete recommended additional treatment?
Participants will take part in a prehabilitation program during their treatment period before surgery. The program includes visits with physical therapy, nutrition, and health psychology. Participants will meet with each specialty at least twice before surgery. They will also complete questionnaires and tests that measure physical function, diet and weight, emotional well-being, and quality of life. After surgery, information about recovery and additional cancer treatment will be collected from medical records for up to 120 days.
Researchers will compare the outcomes of participants who receive the prehabilitation program with outcomes from similar patients who previously received care at Fox Chase Cancer Center but did not participate in this study.
Eligibility Criteria
Inclusion Criteria:
* Evidence of probable or confirmed primary or recurrent malignant neoplasm of any stage
* Planned to undergo neoadjuvant chemotherapy or chemoradiation
* Eligible surgical candidate for one of the following procedures: pancreatectomy, gastrectomy, esophagectomy, cystectomy, low anterior resection, abdominoperineal resection, or cytoreductive surgery with heated intraperitoneal chemotherapy
* Age greater than 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ability to understand and willingness to sign a written informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization document
Exclusion Criteria:
* Unable to complete study requirements, such as attending a minimum of two visits for each specialty referral. This will be assessed at the final preoperative visit, at which time the participant may be discontinued from the study and replaced. Participants will not be excluded due to lack of insurance coverage for health psychology visits.
* Does not proceed to surgery at an affiliated institution
* Pregnant or breastfeeding
Source: ClinicalTrials.gov (NCT07638410). StuddyBuddy aggregates publicly available trial information.