HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery (HOPE)
H.O.P.E. Healing Optimization Through Preoperative Engagement: A Prospective Single Cohort Study to Evaluate the Effect of a Prehabilitation Program on Preoperative Outcomes in Upper GI Surgical Oncology Patients
연구 개요
상세 설명
Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:
- Improved protein rich nutrition with specific immunonutrition recommendations,
- Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,
- Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and
- Disease specific education
These interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.
The preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Louisiana
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New Orleans, Louisiana, 미국, 70471
- Ochsner Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).
- All patients must be 25 to 80 years of age.
- All patients must have a diagnosis of cancer.
- > 10 pound unintentional weight loss within 1 year
- Ability to perform grip strength test and Timed Up and Go (TUG) test
- Willingness to participate in the study, document compliance, and attend clinical appointments
All patients must be undergoing one of the following major elective surgical oncologic resections with curative intent:
- Pancreaticoduodenectomy for pancreatic cancer
- Distal pancreatectomy / splenectomy for pancreatic cancer
- Esophageal robotic assisted laparoscopic thoracoscopic esophagectomy for esophageal cancer
- Laparoscopic or open, partial or total gastrectomy for gastric cancer
Exclusion Criteria:
- All patients not undergoing oncologic or major resections.
- All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.
- All patients that are unable to participate in an activity program.
- All patients unable to wear an electronic activity monitoring device.
- All patients not wanting to follow a specific nutritional and breathing intervention.
- All patients that are not able or wishing to consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Frail
Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
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Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
다른 이름들:
Walking and Inspiratory Muscle Training
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활성 비교기: Not Frail
Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions
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Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
다른 이름들:
Walking and Inspiratory Muscle Training
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frailty Measurement
기간: 4 Weeks
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Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
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4 Weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vitamin levels
기간: 4 Weeks
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4 Weeks
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Quality of Life (QoL) Assessment
기간: 4 Weeks
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QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health
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4 Weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Siobhan M Trotter, DNP, Ochsner Health System
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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