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Prehabilitation in High-risk Oncologic Surgery

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 120 days
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether support before major belly surgery can help adults with cancer recover better. It is for people older than 18 who will receive cancer treatment before surgery. The program includes physical therapy, nutrition care, and support for emotional health.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have likely or confirmed cancer of any stage, whether new or returned.
  • Plan to have chemotherapy, with or without radiation, before surgery.
  • Be able to have one of these surgeries: removal of all or part of the pancreas, stomach, food pipe, or bladder; certain surgeries to remove the rectum, with or without the anus; or tumor removal with heated chemotherapy inside the belly.
  • Be older than 18.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours (ECOG activity score of 0 to 2).
  • Be able to understand and willing to sign forms agreeing to join the study and allowing use of your health information.

Who can't join

  • Cannot complete study tasks, including at least two visits each for physical therapy, nutrition, and emotional health support. Lack of insurance coverage for emotional health visits alone will not exclude you.
  • Do not go on to have surgery at a hospital linked to the study.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

PA