Prehabilitation in High-risk Oncologic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Multidisciplinary Prehabilitation Program

    Behavioral

    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.

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Multidisciplinary Prehabilitation ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

30-Day Rate of Death or Serious Complications 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.

Time frame
Within 30 days after surgery

Secondary outcomes

1

30-Day Death or Serious Complications by Surgical Cohort

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.

Time frame
30 days after surgery
2

Change in Physical Function, Nutritional Status, and Emotional Well-Being

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.

Time frame
Baseline through final preoperative evaluation (up to 6 months before surgery)
3

Postoperative Surgical and Oncologic Outcomes

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.

Time frame
From surgery through 120 days after surgery

Other outcomes

Sponsors and contacts

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