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Prehabilitation in High-risk Oncologic Surgery

9 juin 2026 mis à jour par: Fox Chase Cancer Center

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

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

180

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Multidisciplinary Prehabilitation Program
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.
Comportemental: 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 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
30-Day Rate of Death or Serious Complications After Surgery
Délai: Within 30 days 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
30-Day Death or Serious Complications by Surgical Cohort
Délai: 30 days after surgery
Incidence of 30-day death or serious complications (DSC) among participants undergoing partial or complete pancreatectomy, low anterior resection or abdominoperineal resection, esophagectomy or major gastrectomy, cystectomy, cytoreductive surgery with HIPEC, or other major oncologic procedures. Outcomes will be compared with matched retrospective controls.
30 days after surgery
Postoperative Surgical and Oncologic Outcomes
Délai: From surgery through 120 days after surgery
Evaluation of postoperative outcomes including primary surgical admission length of stay, time to initiation of adjuvant therapy, and rate of completion of recommended adjuvant therapy compared with matched retrospective controls.
From surgery through 120 days after surgery
Change in Physical Function, Nutritional Status, and Emotional Well-Being
Délai: Baseline through final preoperative evaluation (up to 6 months before surgery)
Assessment of the effect of prehabilitation on physical fitness, nutritional status, and emotional well-being, including grip strength, 30-second sit-to-stand test performance, gait speed or 2-minute walk test completion, resting heart rate, skeletal muscle mass-to-height ratio, body weight, Healthy Eating Index score assessed using Vioscreen, Patient Health Questionnaire-9 (PHQ-9) score, Generalized Anxiety Disorder-7 (GAD-7) questionnaire score, and Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) score.
Baseline through final preoperative evaluation (up to 6 months before surgery)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fox Chase Cancer Center

Les enquêteurs

  • Chercheur principal: Stephanie Gzreco, MD, Fox Chase Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

15 décembre 2029

Achèvement de l'étude (Estimé)

15 mars 2030

Dates d'inscription aux études

Première soumission

5 juin 2026

Première soumission répondant aux critères de contrôle qualité

5 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SURG-236

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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