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

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ClinicalTrials.gov Identifier: NCT02850172
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Behavioral: Walk, Eat, & Breathe Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer: A Randomized Controlled Trial
Actual Study Start Date : May 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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
  1. Walking exercise: 3 times per week, 20~30 mins per section
  2. Eat: nutritional assessment and advice weekly
  3. 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.



Primary Outcome Measures :
  1. Body weight [ Time Frame: 5 months ]
    Record the trajectory of body weight during cancer treatment

  2. Lean muscle mass [ Time Frame: 5 months ]
    Record the trajectory of lean muscle mass during cancer treatment using bioelectrical impedance analysis

  3. functional walking capacity [ Time Frame: 5 months ]
    Record the trajectory of walking capacity during cancer treatment using 6-min walk test

  4. hand-grip strength [ Time Frame: 5 months ]
    Record the trajectory of hand-grip strength during cancer treatment using Hand-held dynamometer

  5. pulmonary function [ Time Frame: 5 months ]
    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%.

  6. maximal inspiratory pressure [ Time Frame: 5 months ]
    Record the trajectory of maximal inspiratory pressure during cancer treatment using inspiratory training device: POWERbreathe KH1

  7. anxiety and depression (HADS questionnaire) [ Time Frame: 5 months ]
    Record the trajectory of anxiety and depression during cancer treatment

  8. quality of life (EORTC-QLQ-C30 questionnaire) [ Time Frame: 5 months ]
    Record the trajectory of quality of life during cancer treatment

  9. severity of symptom (QLQ-OES18 questionnaire) [ Time Frame: 5 months ]
    Record the trajectory of severity of symptom during cancer treatment


Secondary Outcome Measures :
  1. chemoradiotherapy-related toxicity (CTCAE grading system) [ Time Frame: 5 months ]
    Record the severity of chemoradiotherapy-related toxicity during cancer treatment

  2. length of hospital stay [ Time Frame: 5 months ]
    Record the length of hospital stay for esophagectomy

  3. treatment interruptions [ Time Frame: 5 months ]
    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

  4. unplanned hospital admission [ Time Frame: 5 months ]
    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. postoperative pulmonary complications [ Time Frame: 30 days ]
    Record the incidence of postoperative pulmonary complications included pneumonia, acute respiratory distress syndrome (ARDS) and respiratory insufficiency developing within 30 days after surgery

  6. length of mechanical ventilation [ Time Frame: 30 days ]
    Record the length of mechanical ventilation after esophagectomy (coded as hours)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850172


Contacts
Contact: Yu-Juan Xu, MSN +886-2-23123456 ext 88438 yujuanxu@kimo.com
Contact: Cheryl Chia-Hui Chen, PhD +886-2-23123456 ext 88438 cherylchen@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Yu-Juan Xu    +886-2-23123456 ext 88438    yujuanxu@kimo.com   
Contact: Cheryl Chia-Hui Chen    +886-2-33222390    cherylchen@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Cheryl Chia-Hui Chen, PhD National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02850172     History of Changes
Other Study ID Numbers: 201602045RINC
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Taiwan University Hospital:
nutrition
exercise
inspiratory muscle training

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases