UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042059 |
|---|---|
| Receipt number | R000046905 |
| Scientific Title | Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial- |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2020/10/09 01:41:04 |
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Basic information
Public title
Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Acronym
Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Scientific Title
Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Scientific Title:Acronym
Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the physical and psychological effects of footbaths on cancer patients undergoing outpatient chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HADS of anxiety/depressive changes before and after chemotherapy in patients who received two outpatient chemotherapy treatments within a period of 3 to 4 weeks, and those who performed foot bath before chemotherapy and those who did not. , Evaluate with POMS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Control group: Patients undergoing two outpatient chemotherapy within a period of 3-4
weeks Perform routine nursing care.
Interventions/Control_2
Control group: Three foot baths are given to patients receiving two outpatient chemotherapy within a period of 3-4 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
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
atients with gastrointestinal cancer who have received outpatient chemotherapy between the ages of 45 and 75 and have been notified of cancer, and who have started outpatient chemotherapy within 1 year and are continuing Stage III-IV. Of these, two outpatient chemotherapy sessions are planned within a period of 3 to 4 weeks, and the physical symptoms are stable regardless of the presence or absence of recurrence, and Performance Status Grade 0 to 1, it is possible to maintain a sitting position for about 15 minutes. Those who have no wounds or skin lesions on their lower legs, can be immersed in hot water, have no mental illness, are not taking psychotropic drugs, and can have daily conversations and fill out questionnaires
Key exclusion criteria
Exclude patients with weekly outpatient chemotherapy, those who have an allergic reaction such as urticaria due to thermal stimulation, if the drug used in the chemotherapy may be affected by heat and the doctor's permission is not obtained.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Iwawaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Doctoral Program, Graduate School of Health and Nursing
Zip code
602-0857
Address
410 Nakagoryocho, Kamigyo-ku, Kyoto City, Kyoto Prefecture
TEL
075-251-5111
iwawaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Okita |
Organization
Kansai Medical University Hospital
Division name
Department of Nursing
Zip code
573-1191
Address
2-3-1, Shinmachi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
zayuzayu2000@yahoo.co.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Doctoral Program, Graduate School of Health and Nursing
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Doctoral Program, Graduate School of Health and Nursing
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
Kyoto Prefectural University of Medicine
Address
410 Nakagoryocho, Kamigyo-ku, Kyoto City, Kyoto Prefecture
Tel
0752515111
iwawaki@koto.kpu-m.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
関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 01 | 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
| 2020 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046905
