Effects of a “Walk, Eat, &Amp; Breathe” Nursing Intervention for Patients with Esophageal Cancer: a Randomized Controlled Trial

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Project title/計畫英文名

Project Number/計畫編號

MOST105-2314-B002-111-MY2

Translated Name/計畫中文名

Walk, Eat, & Breathe 護理介入方案改善食道癌病患的營養、身體活動、肺功能與情緒安適之隨機臨床試驗

Project Principal Investigator/計畫主持人

CHERYL CHIA-HUI CHEN

Co-Investigator(s)/共同執行人

CHIA-HSIEN CHENG
FEI-HSIU HSIAO
JANG-MING LEE
PEI-MING HUANG

Funding Organization

Ministry of Science and Technology

Co-Investigator(s)/共同執行人

黃冠華

Department/Unit

School of Nursing

Website

link

Start date/計畫起

01-08-2017

Expected Completion/計畫迄

31-07-2018

摘要：食道癌治療相當艱辛與漫長，確診時多屬中晚期，病人需先接受前導性放射化學治療(neoadjuvant concurrent chemoradiotherapy; CCRT)以縮小腫瘤，再接受食道切除與重建手術。治療期間，病人的營養、身體功能、情緒安適持續惡化，使得術後出現肺部合併症的風險提高。本研究結合營養衛教、走路運動與吸氣肌訓練，形成一套護理介入方案(Walk，Eat, & Breathe)。介入的目的在協助病人從CCRT 到食道切除與重建手術後一個月期間(共約四個月），可維持良好的營養、身體活動功能、肺功能與情緒安適，並減少治療與手術相關合併症，縮短食道切除與重建手術的住院天數。本研究為三年期的分層隨機臨床試驗，以144名初次診斷食道癌，預定接受前導性放射化學治療與食道切除與重建手術之患者為對象，隨機分派為實驗組及對照組。實驗組接受Walk，Eat，& Breathe，對照組接受常規照護。兩組分別於CCRT 前、CCRT結束時、術前、術後一個月，評估病人的營養【體重、肌肉質量】、身體活動功能【握力、六分鐘步行距離】、肺功能【用力肺活量、一秒用力呼氣量、吸氣肌肌力】、與情緒安適【焦慮/憂鬱症狀、生活品質】四大結果指標；此外，治療與手術相關合併症(包括癌症治療副作用、治療減量或中斷、非預期住院、術後肺部合併症、與呼吸器使用時數)及手術住院天數也將一併被檢視。
Abstract: Esophageal cancer is a devastating disease with poor prognosis. This is largely due to its rather insidious progression, so most patients were diagnosed with advanced cancer stage. Patients with advanced stage therefore have to be treated with neoadjuvant chemoradiotherapy (CCRT) to shrink the tumor and followed by a curative surgery (i.e., esophagectomy). Patients’ nutritional status, functional walking capacity, and emotional well-being are substantially deteriorated, which often increase the incidence of postoperative pulmonary complications, thus the risk of surgical death is greatly increased. To better support patients with esophageal cancer, during this critical treatment course (approximate 4 months in length), we develop a “Walk，Eat，& Breathe” nursing intervention consisting of nutritional advice, walking exercise, and inspiratory muscle training. The purpose of this stratified randomized controlled trial (RCT) is to test the effects of Walk，Eat，& Breathe on preserving patients’ nutritional status, functional walking capacity, pulmonary function, and emotional well-being during the CCRT and surgery course. Additionally, effects to reduce treatment-related complications and length of hospital stay for esophagectomy will beevaluated between experimental and control groups.For this three-year stratified RCT, a total of 144 consecutive patients will be enrolled to ensure the power of study. Patients will be eligible for the study if they had histologically documented, locally advanced tumors of the esophagus, defined as American Joint Committee on Cancer (AJCC) stage IIB or higher, were scheduled for neoadjuvant chemoradiotherapy and subsequent curative surgery, and had no contraindication precluding walking. After obtaining the consent, participants will be first stratified by two important covariates [intake status (oral intake or tube feeding) and tumor location (upper third or middle & lower third of esophagus)] and then randomized separately into the experimental or control group, according to computer-generated randomization tables.Participants in the experimental group will receive “Walk, Eat, & Breathe” at initiation of CCRT and ends before curative surgery. Participants in the control group received usual care. Participants will undergo measurements at four points in time: before CCRT, after CCRT, before surgery, and 1-month after surgery. Primary endpoints include nutritional status (body weight, lean muscle mass), functional walking capacity (hand-grip strength, 6-min walking distance), pulmonary function (forced vital capacity, forced expiratory volume in 1 second, maximal inspiratory pressure), and emotional well-being (anxiety/depression, quality of life). Secondary endpoints include treatment-related complications and length of hospital stay for esophagectomy. The treatment-related complications will include chemoradiotherapy-related toxicity (i.e., neutropenia, esophagitis), rates of interruptions (i.e., discontinuation, reduction) in chemotherapy or radiotherapy, unplanned hospital admission, incidence of postoperative pulmonary complications, and length of mechanical ventilation for surgery.

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Effects of a “Walk, Eat, &Amp; Breathe” Nursing Intervention for Patients with Esophageal Cancer: a Randomized Controlled Trial

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