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

NCT02850172 | Unknown

• 1 other identifier: 201602045RINC
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

nutrition; exercise; inspiratory muscle training

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• chemoradiotherapy-related toxicity (CTCAE grading system)

  5 months

• length of hospital stay

  5 months

• treatment interruptions

  5 months

• unplanned hospital admission

  5 months

• postoperative pulmonary complications

  30 days

Study Arms (2)

Walk, eat, & breathe group

EXPERIMENTAL

Participants in the experimental group will receive "Walk, Eat, \& Breathe" at initiation of CCRT and ends before curative surgery.

Behavioral: Walk, Eat, & Breathe

Control group

NO INTERVENTION

Participants in the control group received usual care.

Interventions

Walk, Eat, & Breathe BEHAVIORAL

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

Walk, eat, & breathe group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patient is cognitively capable to understand the trial;
• 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;
• the patient is willing to sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Motor Activity

Interventions

Walking; Eating

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Cheryl Chia-Hui Chen, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Juan Xu, MSN

CONTACT

+886-2-23123456; yujuanxu@kimo.com

Cheryl Chia-Hui Chen, PhD

CONTACT

+886-2-23123456; cherylchen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: July 29, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

TW (1)