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Randomized Clinical Trial Investigating Multidimensional Prehabilitation in Pancreatic Surgery for participants with Pancreatic and Periampullary Neoplasms
Frailty is independently associated with an increased risk of adverse outcomes after major surgery, including pancreatic resection. Prehabilitation aims to optimize modifiable risk factors to improve participants' baseline health prior to surgery. Multiple studies with participants undergoing pancreatic surgery have investigated the impact of prehabilitation on preoperative health metrics as well as postoperative outcomes. The majority of these studies focused only on exercise; if nutritional and/or psychological status were assessed, these dimensions were not intervened upon in prehabilitation regimens or reassessed postoperatively. This randomized controlled trial (RCT) is designed to assess the impact of physical and nutritional prehabilitation on participants' perioperative condition for those undergoing pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (Standard of Care) | Active Comparator | Participants will receive the current standard preoperative education and counseling. Participants will receive information regarding exercise and nutrition from a member of the surgical team. Participants will meet with a behavioral medicine specialist for additional education regarding factors affecting postoperative stress and relaxation techniques. Participants who are actively smoking will be counseled regarding smoking cessation and offered a referral to smoking cessation resources. |
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| Intervention Arm (Prehabilitation) | Experimental | Participants in the intervention arm will receive all of the standard of care, as listed above, as well as individualized exercise and nutritional prehabilitation regimens. During the data analysis, participants will be subdivided into treatment groups, upfront surgical resection versus neoadjuvant chemotherapy, in order to determine whether length of prehabilitation affected outcomes and distinguish any possible effect of chemotherapy toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Participants will meet with an exercise physiologist to undergo evaluation and develop individualized regimens for prehabilitation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in participants physical capacity, as represented by hand grip strength | Previous studies have demonstrated that grip strength is a predictor of surgical outcomes and mortality in cancer participants. Grip strength will be measured utilizing the Jamar Dynamometer. | 3 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | Death due to any cause postoperatively. | Up to 90 days after the surgery |
| Morbidity rate | Classified according to the Clavien-Dindo Classification of postoperative complications. |
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Inclusion Criteria:
Participants > 18 years old with ECOG performance status 0-2 and ASA score ≤3
Requiring pancreatic resection for diagnosed or suspected pancreatic and periampullary neoplasms
Surgery scheduled at least 2 weeks after the initial surgical evaluation
Fluency in English
Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
Exclusion Criteria:
Screening: Physical Activity Readiness - Questionnaire (PAR-Q+)
Inability to provide own informed consent
Inability to read or verbally understand questionnaires in English
Impaired hearing that creates a barrier for telephone follow-up
Visual deficit that would cause exercise to be hazardous
Emergent or urgent surgeries
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D001524 | Behavioral Medicine |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Nutritional | Dietary Supplement | Participants will meet with a nutritionist to undergo evaluation and develop individualized regimens for prehabilitation. |
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| Behavioral Medicine | Behavioral | Participants will have 1 appointment with behavioral medicine - all participants will meet with the same behavioral medicine specialist to ensure consistency. Participants will receive education regarding factors that affect postoperative recovery and relaxation techniques. Participants will also have the option to request faith support. |
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| Smoking Cessation | Behavioral | Participants who are actively smoking will be counseled regarding smoking cessation during their preoperative appointment with a member of the surgical team. They will also be offered a referral to smoking cessation resources. |
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| Up to 90 days after the surgery |
| Physical capacity as represented by 30s CST (Chair Stand Test ) | Participants rise to full standing position from sitting in a chair as many times as possible within 30 seconds. The 30s CST has been utilized as a reliable test of lower extremity strength. | 3 weeks after the surgery |
| Physical capacity as represented by 6-Minute Walk Test | Participants will walk as far as possible in 6 min at a comfortable pace but do not run or jog. If participants cannot complete the full 6 min walk, then record the time and distance walked and the reason for stopping early. | 3 weeks after the surgery |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |