Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer
NCT ID: NCT02850172
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2016-05-31
2019-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Walk, eat, & breathe group
Participants in the experimental group will receive "Walk, Eat, \& Breathe" at initiation of CCRT and ends before curative surgery.
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
Control group
Participants in the control group received usual care.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Cheryl Chia-Hui Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201602045RINC
Identifier Type: -
Identifier Source: org_study_id