UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021540 |
|---|---|
| Receipt number | R000024201 |
| Scientific Title | Relevance of nutritional counseling and QOL of cancer chemotherapy outpatients |
| Date of disclosure of the study information | 2016/06/25 |
| Last modified on | 2024/04/05 17:45:47 |
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Basic information
Public title
Relevance of nutritional counseling and QOL of cancer chemotherapy outpatients
Acronym
Relevance of nutritional counseling and QOL of cancer chemotherapy outpatients
Scientific Title
Relevance of nutritional counseling and QOL of cancer chemotherapy outpatients
Scientific Title:Acronym
Relevance of nutritional counseling and QOL of cancer chemotherapy outpatients
Region
| Japan |
Condition
Condition
Outpatients with chemotherapy cancer patients
Classification by specialty
| Gastroenterology | Pneumology | Gastrointestinal surgery |
| Chest surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is to
(1)explore the factors associated with eating and nutritional state, (2)examine the influence of nutritional counseling on the QOL of cancer chemotherapy outpatients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Quality of Life score : European Organization for Research and Treatment of Cancer(EORTC QLQ-C30)
Key secondary outcomes
1.Nutritional State score : Patient-Generated Subjective Global Assessment(PG-SGA)
2.Patients experience of eating-related distress
3. Food Frequency Questionnaire(FFQ)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Who has been notify a diagnosis head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, lung cancer and breast cancer.
2)Who has chemotherapy as an outpatient.
3)Who has physical status to acceptable examination.
4)Who can understand Japanese and provide answers for questions.
5)Who don't have serious cognition
Key exclusion criteria
The primary physician estimate that who cannot participate in the intervention or answer the questionnaire because of his/her physical, mental, or cognitive function.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Nakajima |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Clinical Nutrition
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5252
yasu.nakajima.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Koshimoto |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Section of Liaison Psychiatry and Palliative Medicine
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5859
Homepage URL
skoshimoto.lppm@tmd.ac.jp
Sponsor or person
Institute
Medical Hospital, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
Tel
03-5803-5960
kenkyo.adm@cmn.tmd.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
DOI: 10.1007/s00520-018-4628-9
Publication of results
Partially published
Result
URL related to results and publications
doi: 10.1007/s00520-018-4628-9
Number of participants that the trial has enrolled
151
Results
Patients' experience of eating-related distress and demand for nutritional counselling were significantly associated, particularly in regard to 'conflicts over food between patients and the people surrounding them' (p = 0.005), 'concerns about food' (p = 0.007) and 'self-motivated effect related to nutrition' (p = 0.018).
Results date posted
| 2023 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A survey was conducted among adult patients receiving outpatient chemotherapy at the Tokyo Medical and Dental University Hospital. The participants completed self-report questionnaires, which included questions on their nutritional state (Patient-Generated Subjective Global Assessment Short Form), experience of eating-related distress and quality of life (QOL) (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30).
Participant flow
A survey was conducted among adult patients receiving outpatient chemotherapy at the Tokyo Medical and Dental University Hospital. The participants completed self-report questionnaires, which included questions on their nutritional state (Patient-Generated Subjective Global Assessment Short Form), experience of eating-related distress and quality of life (QOL) (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30).
Adverse events
None
Outcome measures
PG-SGA SF
EORTC QLQ-C30
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
questionary investigation
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024201
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/09/21 | 栄養研究実施計画書(M2015-578-03).doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/03/29 | need and demand for nutritional couselling and their association with qol..pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/03/29 | need and demand for nutritional couselling and their association with qol..pdf |
