Effect of self-monitoring intervention on oral intake of esophageal cancer patients undergoing chemoradiotherapy

Effect of self-monitoring intervention on oral intake of esophageal cancer patients undergoing chemoradiotherapy - 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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032664

Enrollment

Registered

2018-05-30

Start date

2018-03-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus cancer

Interventions

Both the intervention group and the control group teach how to deal with adverse events of chemoradiotherapy which inhibits oral intake by using pamphlets. For the intervention group, intervention u

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public Contacthayashi hikari

Gunma University Medical College Hospital Nursing Department

h171a007@gunma-u.ac.jp027-220-8389

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026