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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032664
Receipt No. R000035737
Scientific Title Effect of self-monitoring intervention on oral intake of esophageal cancer patients undergoing chemoradiotherapy
Date of disclosure of the study information 2018/05/30
Last modified on 2018/05/21

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Basic information
Public title Effect of self-monitoring intervention on oral intake of esophageal cancer patients undergoing chemoradiotherapy
Acronym It is aimed to clarify the effectiveness of self monitoring for oral intake of esophageal cancer patients who undergo concurrent chemoradiotherapy combined therapy and to consider nursing support that helps maintain patient's QOL and self - efficacy.
Scientific Title Effect of self-monitoring intervention on oral intake of esophageal cancer patients undergoing chemoradiotherapy
Scientific Title:Acronym It is aimed to clarify the effectiveness of self monitoring for oral intake of esophageal cancer patients who undergo concurrent chemoradiotherapy combined therapy and to consider nursing support that helps maintain patient's QOL and self - efficacy.
Region
Japan

Condition
Condition Esophagus cancer
Classification by specialty
Gastrointestinal surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is aimed to clarify the effectiveness of self monitoring for oral intake of esophageal cancer patients who undergo concurrent chemoradiotherapy combined therapy and to consider nursing support that helps maintain patient's QOL and self - efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of qualitative inductive analysis by semistructured interview
Evaluate qualitative changes through content analysis on cognition, emotion, and coping of oral intake, and urge free speech based on the interview guide.
Both the control group and the intervention group are conducted four times before the survey, 3, 6 and 9 weeks after the survey. Main interview contents are as follows.
(1) Changes in Oral Intake
(2) What I felt in a change in oral intake
(3) Things devised by oral ingestion
(4) How do you think about eating from the mouth
(5) Have you noticed what you did with self-monitoring (intervention group only)
(6) Have you noticed how researchers were visiting once a week (intervention group only)
Key secondary outcomes Usage scale
VAS
Adverse events Control sensation of dietary intake, degree of delicious meal, confidence confronting meals
QLQ-C30
Measure QOL of cancer patients
QLQ-OES 18
QOL measurement of esophageal cancer patients
Thermometers and troublesome thermometers
Measures the degree of difficulty and troubles of adverse events
Self-efficacy scale for advanced cancer (SEAC)
Measure changes in self-efficacy due to appropriate cognition of symptoms
Blood data (serum albumin value peripheral lymphocyte count serum total protein BMI CRP Hb), body weight, BMI
Objective measurement of the effect of ingestion by nutritional index value
Measurement date
Interview, VAS, QLQ-C30, QLQ-OES18, hot and cold thermometer, SEAC
A total of seven times from 1st to 6th week and 9th week: blood data, weight, BMI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Both the intervention group and the control group teach how to deal with adverse events of chemoradiotherapy which inhibits oral intake by using pamphlets.
Interventions/Control_2 For the intervention group, intervention using the individual sessions until the sixth week in hospitalization is performed once as the first time on the next day of the recording diary and chemoradiotherapy start date. The intervention period is 9 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with esophageal cancer who will receive chemoradiotherapy
2) Patients who have swallowing disorder grade of 2 or less in CTCAEver 4 (Common Terminology Standards for Adverse Events v 4.0) and have not instructed fasting at the start of chemoradiotherapy
3) Patients whose Performance Status Score (PS) is 0 to 2
4) There is no obvious mental illness and has cognitive and language ability to the extent that everyday conversation is possible
5) The subjects themselves understand the purpose of this research and agree with research cooperation
Key exclusion criteria Patients who are difficult to measure, interview, write diary due to physical and mental reasons
patients who have swallowing disorder Grade 3 or higher at CTCAEver 4 at the start of treatment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kiyoko kanda
Organization Gunma University
Division name Graduate School of Health Sciences
Zip code
Address Gunma Prefecture 3-39-15 Showa-machi Maebashi City
TEL 027-220-8292
Email kkanda@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name hikari hayashi
Organization Gunma University
Division name Medical College Hospital Nursing Department
Zip code
Address Gunma Prefecture 3-39-15 Showa-machi Maebashi City
TEL 027-220-8389
Homepage URL
Email h171a007@gunma-u.ac.jp

Sponsor
Institute Gunma University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 群馬大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 21 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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