Esophageal CancerNCT02850172
Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer
A study testing Walk, Eat, & Breathe in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Walk, Eat, & Breathe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10048
Yu-Juan Xu, +886-2-23123456 ext. 88438, yujuanxu@kimo.com
Cheryl Chia-Hui Chen, +886-2-33222390, cherylchen@ntu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Walk, Eat, & Breathe
- Keywords
- nutrition, exercise, inspiratory muscle training
- Medical subject headings
- Esophageal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk, Eat, & BreatheBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Walk, eat, & breathe group | Experimental | Participants in the experimental group will receive "Walk, Eat, \& Breathe" at initiation of CCRT and ends before curative surgery. Receives: Behavioral: Walk, Eat, & Breathe |
| Control group | No intervention | Participants in the control group received usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Record the trajectory of body weight during cancer treatment
Measured: 5 months
Lean muscle mass
Record the trajectory of lean muscle mass during cancer treatment using bioelectrical impedance analysis
Measured: 5 months
functional walking capacity
Record the trajectory of walking capacity during cancer treatment using 6-min walk test
Measured: 5 months
hand-grip strength
Record the trajectory of hand-grip strength during cancer treatment using Hand-held dynamometer
Measured: 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%.
Measured: 5 months
maximal inspiratory pressure
Record the trajectory of maximal inspiratory pressure during cancer treatment using inspiratory training device: POWERbreathe KH1
Measured: 5 months
anxiety and depression (HADS questionnaire)
Record the trajectory of anxiety and depression during cancer treatment
Measured: 5 months
quality of life (EORTC-QLQ-C30 questionnaire)
Record the trajectory of quality of life during cancer treatment
Measured: 5 months
severity of symptom (QLQ-OES18 questionnaire)
Record the trajectory of severity of symptom during cancer treatment
Measured: 5 months
Secondary outcomes (6)
chemoradiotherapy-related toxicity (CTCAE grading system)
Record the severity of chemoradiotherapy-related toxicity during cancer treatment
Measured: 5 months
length of hospital stay
Record the length of hospital stay for esophagectomy
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
length of mechanical ventilation
Record the length of mechanical ventilation after esophagectomy (coded as hours)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Chia-Hui Chen, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850172
- Sponsor's protocol ID
- 201602045RINC
- Status last verified
- Sep 2017
- First submitted
- 11 May 2016
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02850172
- Acronym / sponsor ID
- 201602045RINC
- Conditions
- Esophageal Cancer
- Keywords
- nutrition, exercise, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk, eat, & breathe group | Experimental | Behavioral: Walk, Eat, & BreatheParticipants in the experimental group will receive "Walk, Eat, \& Breathe" at initiation of CCRT and ends before curative surgery. |
| Control group | No intervention | –Participants in the control group received usual care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk, Eat, & Breathe1. 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 | Behavioural | Walk, eat, & breathe group |
Primary outcome
Body weight
Time frame: 5 months
Record the trajectory of body weight during cancer treatment
Lean muscle mass
Time frame: 5 months
Record the trajectory of lean muscle mass during cancer treatment using bioelectrical impedance analysis
functional walking capacity
Time frame: 5 months
Record the trajectory of walking capacity during cancer treatment using 6-min walk test
hand-grip strength
Time frame: 5 months
Record the trajectory of hand-grip strength during cancer treatment using Hand-held dynamometer
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%.
maximal inspiratory pressure
Time frame: 5 months
Record the trajectory of maximal inspiratory pressure during cancer treatment using inspiratory training device: POWERbreathe KH1
anxiety and depression (HADS questionnaire)
Time frame: 5 months
Record the trajectory of anxiety and depression during cancer treatment
quality of life (EORTC-QLQ-C30 questionnaire)
Time frame: 5 months
Record the trajectory of quality of life during cancer treatment
severity of symptom (QLQ-OES18 questionnaire)
Time frame: 5 months
Record the trajectory of severity of symptom during cancer treatment
6 secondary outcomes
chemoradiotherapy-related toxicity (CTCAE grading system)
Time frame: 5 months
length of hospital stay
Time frame: 5 months
treatment interruptions
Time frame: 5 months
unplanned hospital admission
Time frame: 5 months
postoperative pulmonary complications
Time frame: 30 days
length of mechanical ventilation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Chia-Hui Chen, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk, Eat, & Breathe in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Juan Xu, MSN (+886-2-23123456 ext. 88438, yujuanxu@kimo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 5 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.