Prehabilitation in High-risk Oncologic Surgery

NCT07638410 | Not Yet Recruiting DMC

• 1 other identifier: SURG-236
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Does prehabilitation reduce the number of participants who die or have serious complications within 30 days after surgery?
2. 2.Does prehabilitation improve physical strength and fitness, nutritional status, emotional well-being, and quality of life before surgery?
3. 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?

Conditions

Pancreatic Cancer; Colo-rectal Cancer; Gastric Cancer; Esophageal Cancer; Bladder Cancer; Ovarian Cancer; Abdominal Surgery Complications

Keywords

Prehabilitation; Preoperative Rehabilitation; Multimodal Prehabilitation; Major Abdominal Surgery; Oncologic Surgery; Neoadjuvant Therapy; Postoperative Complications; Cancer Surgery

Outcome Measures

Primary Outcomes (1)

• 30-Day Rate of Death or Serious Complications After Surgery

  Percentage of participants who experience death or at least one serious postoperative complication within 30 days after the index surgery, as defined by the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). Outcomes in participants receiving the multidisciplinary prehabilitation program will be compared with outcomes in matched retrospective controls.

  Within 30 days after surgery

Secondary Outcomes (3)

• 30-Day Death or Serious Complications by Surgical Cohort

  30 days after surgery

• Change in Physical Function, Nutritional Status, and Emotional Well-Being

  Baseline through final preoperative evaluation (up to 6 months before surgery)

• Postoperative Surgical and Oncologic Outcomes

  From surgery through 120 days after surgery

Study Arms (1)

Multidisciplinary Prehabilitation Program

EXPERIMENTAL

Participants will receive a multidisciplinary prehabilitation program during the preoperative period while undergoing neoadjuvant treatment before planned high-risk abdominal oncologic surgery. The program includes supportive care provided by physical therapy, nutrition, and health psychology to prepare participants for surgery and support physical, nutritional, and emotional well-being.

Behavioral: Multidisciplinary Prehabilitation Program

Interventions

Multidisciplinary Prehabilitation Program BEHAVIORAL

A multidisciplinary prehabilitation program delivered during neoadjuvant therapy before planned high-risk abdominal oncologic surgery. The program includes physical therapy, nutrition, and health psychology support, with approximately monthly visits and at least two visits with each specialty before surgery. Physical therapy includes an individualized home strengthening and aerobic exercise program supported by resistance bands, a pedometer, and an exercise log. Nutrition includes individualized dietary counseling focused on maintaining weight and meeting protein needs, with oral nutritional supplementation when clinically indicated. Health psychology includes assessment, supportive care planning, and referral to additional psychosocial resources when needed. The intervention is completed before surgery; postoperative data collection is for follow-up only.

Multidisciplinary Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Colonic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Urinary Bladder Neoplasms; Ovarian Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie Gzreco, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Greco, MD

CONTACT

2152143719; stephanie.greco@fccc.edu

Henkel Valentine, PhD

CONTACT

2678820820; henkel.valentine@fccc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All prospectively enrolled participants will receive the multidisciplinary prehabilitation intervention during neoadjuvant therapy before planned high-risk abdominal oncologic surgery. Outcomes will be compared with outcomes from matched retrospective controls who received care before initiation of the prospective study and were not assigned to the study intervention.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): March 15, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share