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Prehabilitation in High-risk Oncologic Surgery

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

180

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
30-Day Rate of Death or Serious Complications After Surgery
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
30-Day Death or Serious Complications by Surgical Cohort
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fox Chase Cancer Center

Ermittler

  • Hauptermittler: Stephanie Gzreco, MD, Fox Chase Cancer Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

15. Dezember 2029

Studienabschluss (Geschätzt)

15. März 2030

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SURG-236

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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