Prehabilitation in High-risk Oncologic Surgery

Официальное название

SURG-236: Prehabilitation in High-risk Oncologic Surgery: A Prospective Cohort Study

Обзор

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.

Подробное описание

Patients with cancer who receive treatment before major abdominal surgery may experience loss of strength, reduced nutritional status, fatigue, and emotional distress during the period leading up to surgery. These challenges may affect their ability to tolerate surgery and recover after the procedure. Prehabilitation is an approach intended to improve a patient's condition before surgery through coordinated supportive care.

This is a prospective cohort study evaluating a multidisciplinary prehabilitation program for adults with cancer who are undergoing neoadjuvant treatment before planned high-risk abdominal oncologic surgery. The program integrates physical therapy, nutritional support, and health psychology during the preoperative treatment period. The study will evaluate whether this approach is associated with improved postoperative outcomes and improved measures of physical function, nutritional status, and emotional well-being.

Outcomes for participants enrolled in the prospective prehabilitation cohort will be compared with outcomes from matched retrospective controls treated at Fox Chase Cancer Center before initiation of this study. Each prospective participant who proceeds to surgery and is eligible for analysis will be matched with one retrospective control based on relevant clinical and demographic characteristics, including age, sex, smoking status, American Society of Anesthesiologists (ASA) class, and cancer type. When more than one eligible matched control is available, one control will be selected at random.

The study is intended to assess whether a structured, multidisciplinary prehabilitation program can be implemented across several high-risk oncologic surgery populations and whether this approach may support improved recovery and continuity of cancer care after surgery.

Вмешательства

• Поведенческое Multidisciplinary Prehabilitation Program
  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 individualize

Первичные конечные точки

• 30-Day Rate of Death or Serious Complications After Surgery [Срок оценки: Within 30 days after surgery]

Вторичные конечные точки (3)

• 30-Day Death or Serious Complications by Surgical Cohort [Срок оценки: 30 days after surgery]
• Change in Physical Function, Nutritional Status, and Emotional Well-Being [Срок оценки: Baseline through final preoperative evaluation (up to 6 months before surgery)]
• Postoperative Surgical and Oncologic Outcomes [Срок оценки: From surgery through 120 days after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07638410 · SURG-236

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗