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NCT07638410
Prehabilitation in High-risk Oncologic Surgery
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Descripción
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.
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.
Criterios de Elegibilidad
Inclusion Criteria:
- Evidence of probable or confirmed primary or recurrent malignant neoplasm (any stage)
- Planned to undergo neoadjuvant chemotherapy or chemoradiation
- Eligible surgical candidate for the following procedures: pancreatectomy, gastrectomy, esophagectomy, cystectomy, low anterior resection, abdominoperineal resection, or cytoreductive surgery with heated intraperitoneal chemotherapy
- Age \> 18 years.
- ECOG performance status 0 - 2
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Exclusion Criteria:
- Patients who are unable to complete study requirements (e.g. unable to travel to a minimum of two visits for each specialty referral). This will be assessed at final preoperative visit at which time the patient may be disqualified from study and replaced. Patients will not be excluded due to lack of insurance coverage for health psychology visits.
- Patients who do not proceed to surgery at an affiliated institution.
- Patients who are pregnant or breastfeeding
Información del Ensayo
NCT07638410
Aún no reclutando
Sin fase definida
180 participantes
Jun 2026
Dic 2029