UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049409 |
|---|---|
| Receipt number | R000056184 |
| Scientific Title | Cross-sectional observational study on health literacy and choice of complementary and alternative medicine in cancer patients |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2023/11/03 12:14:16 |
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Basic information
Public title
Cross-sectional observational study on health literacy and choice of complementary and alternative medicine in cancer patients
Acronym
Cross-sectional observational study on health literacy and choice of complementary and alternative medicine in cancer patients
Scientific Title
Cross-sectional observational study on health literacy and choice of complementary and alternative medicine in cancer patients
Scientific Title:Acronym
Cross-sectional observational study on health literacy and choice of complementary and alternative medicine in cancer patients
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between health literacy and the choice of complementary and alternative medicine in cancer patients, and examine the communication of medical practitioners
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
health literacy
Key secondary outcomes
Usage status of complementary and alternative medicine, whether or not to consult a doctor, response to side effects
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Cancer patients over 20 years old.
2, Patients who are outpatients or hospitalized for cancer (including outpatient treatment, inpatient treatment, palliative treatment, hospice inpatient treatment, and home treatment) at the time of the questionnaire.
Key exclusion criteria
1, Patients who are healthcare workers.
2, Participants who have experienced cancer (participants who have completed cancer treatment or are in a completely cured state and have not visited the hospital at the time of the questionnaire).
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Osawa |
Organization
Kyoto University Hospital
Division name
Department of Palliative Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL
075-751-4629
osawa_kyoko@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Osawa |
Organization
Kyoto University Hospital
Division name
Department of Palliative Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL
075-751-4629
Homepage URL
osawa_kyoko@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Kyoto University Foundation and Sasakawa Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2022 | Year | 12 | Month | 22 | 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
2068
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1, Evaluation of health literacy in cancer patients and verification of patient factors that affect health literacy.
2, Verification of the relationship between cancer patients' health literacy and the use of complementary and alternative medicine, the presence or absence of consultation with doctors, and the response to side effects.
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056184
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
