Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer

Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer: A Randomized Controlled Trial

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 be evaluated between experimental and control groups.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Behavioral: Walk, Eat, & Breathe

Detailed Description

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 be evaluated 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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Juan Xu, MSN; Phone Number: 88438 +886-2-23123456; Email: yujuanxu@kimo.com
• Study Contact Backup: Name: Cheryl Chia-Hui Chen, PhD; Phone Number: 88438 +886-2-23123456; Email: cherylchen@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10048
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yu-Juan Xu; Phone Number: 88438 +886-2-23123456; Email: yujuanxu@kimo.com
    • Contact: Cheryl Chia-Hui Chen; Phone Number: +886-2-33222390; Email: cherylchen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. the patient is cognitively capable to understand the trial;
2. 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;
3. the patient is willing to sign the informed consent form.

Exclusion Criteria:

1. age <20 years;
2. the patient is unable to communicate in the Chinese language; and
3. the patient has contraindications that limit physical activity such as severe cardiac disease, recent myocardial infarction or uncontrolled hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walk, eat, & breathe group; Participants in the experimental group will receive "Walk, Eat, & Breathe" at initiation of CCRT and ends before curative surgery.	Behavioral: Walk, Eat, & Breathe; Walking exercise: 3 times per week, 20~30 mins per section; Eat: nutritional assessment and advice weekly; Inspiratory muscle training: twice every day, 7 days a week, 6~8 weeks before surgery
No Intervention: Control group; Participants in the control group received usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Record the trajectory of body weight during cancer treatment	5 months
Lean muscle mass	Record the trajectory of lean muscle mass during cancer treatment using bioelectrical impedance analysis	5 months
functional walking capacity	Record the trajectory of walking capacity during cancer treatment using 6-min walk test	5 months
hand-grip strength	Record the trajectory of hand-grip strength during cancer treatment using Hand-held dynamometer	5 months
pulmonary function	Record the trajectory of pulmonary function(FVC, FEV1) during cancer treatment using spirometry. The parameters are recorded with the prediction values of FVC% and FEV1%.	5 months
maximal inspiratory pressure	Record the trajectory of maximal inspiratory pressure during cancer treatment using inspiratory training device: POWERbreathe KH1	5 months
anxiety and depression (HADS questionnaire)	Record the trajectory of anxiety and depression during cancer treatment	5 months
quality of life (EORTC-QLQ-C30 questionnaire)	Record the trajectory of quality of life during cancer treatment	5 months
severity of symptom (QLQ-OES18 questionnaire)	Record the trajectory of severity of symptom during cancer treatment	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemoradiotherapy-related toxicity (CTCAE grading system)	Record the severity of chemoradiotherapy-related toxicity during cancer treatment	5 months
length of hospital stay	Record the length of hospital stay for esophagectomy	5 months
treatment interruptions	Record the "event" of treatment discontinuation or reduction on chemotherapy or radiotherapy. The result was coded as "yes" or "no". The variable are depicted in term of frequency and percentage of participants with treatment interruptions during cancer treatment	5 months
unplanned hospital admission	Record the "event" of unplanned hospital admission. The result was coded as "yes" or "no". The variable are depicted in term of frequency and percentage of participants with unplanned hospital admission during cancer treatment	5 months
postoperative pulmonary complications	Record the incidence of postoperative pulmonary complications included pneumonia, acute respiratory distress syndrome (ARDS) and respiratory insufficiency developing within 30 days after surgery	30 days
length of mechanical ventilation	Record the length of mechanical ventilation after esophagectomy (coded as hours)	30 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Cheryl Chia-Hui Chen, PhD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: exercise; nutrition; inspiratory muscle training
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 201602045RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided