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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850172
• Other study ID #: 201602045RINC
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2016
• Last updated: September 25, 2017
• Start date: May 2016
• Est. completion date: April 2019

Study information

• Verified date: September 2017
• Source: National Taiwan University Hospital
• Contact: Yu-Juan Xu, MSN
• Phone: +886-2-23123456
• Email: yujuanxu[@]kimo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Record the trajectory of body weight during cancer treatment	5 months
Primary	Lean muscle mass	Record the trajectory of lean muscle mass during cancer treatment using bioelectrical impedance analysis	5 months
Primary	functional walking capacity	Record the trajectory of walking capacity during cancer treatment using 6-min walk test	5 months
Primary	hand-grip strength	Record the trajectory of hand-grip strength during cancer treatment using Hand-held dynamometer	5 months
Primary	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
Primary	maximal inspiratory pressure	Record the trajectory of maximal inspiratory pressure during cancer treatment using inspiratory training device: POWERbreathe KH1	5 months
Primary	anxiety and depression (HADS questionnaire)	Record the trajectory of anxiety and depression during cancer treatment	5 months
Primary	quality of life (EORTC-QLQ-C30 questionnaire)	Record the trajectory of quality of life during cancer treatment	5 months
Primary	severity of symptom (QLQ-OES18 questionnaire)	Record the trajectory of severity of symptom during cancer treatment	5 months
Secondary	chemoradiotherapy-related toxicity (CTCAE grading system)	Record the severity of chemoradiotherapy-related toxicity during cancer treatment	5 months
Secondary	length of hospital stay	Record the length of hospital stay for esophagectomy	5 months
Secondary	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
Secondary	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
Secondary	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
Secondary	length of mechanical ventilation	Record the length of mechanical ventilation after esophagectomy (coded as hours)	30 days