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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Louisiana
-
New Orleans、Louisiana、アメリカ、70471
- Ochsner Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
他の名前：
Walking and Inspiratory Muscle Training
|
|
アクティブコンパレータ：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
|
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
他の名前：
Walking and Inspiratory Muscle Training
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frailty Measurement
時間枠：4 Weeks
|
Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
|
4 Weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Vitamin levels
時間枠：4 Weeks
|
4 Weeks
|
|
|
Quality of Life (QoL) Assessment
時間枠：4 Weeks
|
QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health
|
4 Weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Siobhan M Trotter, DNP、Ochsner Health System
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HOPE Study 2018.045
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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