UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032664 |
|---|---|
| Receipt number | 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 | 2020/06/04 21:03:28 |
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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 | ayumi |
| Middle name | |
| Last name | kyota |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
3718511
Address
Gunma Prefecture 3-39-15 Showa-machi Maebashi City
TEL
027-220-8292
kkanda@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | hayashi |
| Middle name | |
| Last name | hikari |
Organization
Gunma University
Division name
Medical College Hospital Nursing Department
Zip code
371-8511
Address
Gunma Prefecture 3-39-15 Showa-machi Maebashi City
TEL
027-220-8389
Homepage URL
h171a007@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Health Sciences
Institute
Department
Personal name
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
gunma university hospital
Address
gunma maebasi shouwamati 3-39-15
Tel
027-220-7111
gunma-u@esct.bvits.com
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
| 2018 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035737
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| Registered date | File name |
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