UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035669 |
|---|---|
| Receipt number | R000040630 |
| Scientific Title | The Effect of Foot-Bathing Care on Fatigue, Mood, Sleep, and QOL in Patients with Lung Cancer Receiving First Chemotherapy. |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2023/07/31 16:26:58 |
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Basic information
Public title
The Effect of Foot-Bathing Care on Fatigue, Mood, Sleep, and QOL in Patients with Lung Cancer Receiving First Chemotherapy.
Acronym
The Effect of Foot-Bathing Care on Fatigue, Mood, Sleep, and QOL in Patients with Lung Cancer Receiving First Chemotherapy.
Scientific Title
The Effect of Foot-Bathing Care on Fatigue, Mood, Sleep, and QOL in Patients with Lung Cancer Receiving First Chemotherapy.
Scientific Title:Acronym
The Effect of Foot-Bathing Care on Fatigue, Mood, Sleep, and QOL in Patients with Lung Cancer Receiving First Chemotherapy.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to clarified to effect of foot-bathing care on fatigue, mood, sleep and QOL in patients
with lung cancer receiving first chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer Fatigue Scale
Key secondary outcomes
Profile of Mood State
OSA sleep inventory MA version
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
10-minute care for foot bathing six times a week
Interventions/Control_2
ordinary care six times a week
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
non small lung cancer
stage 3 or 4
patients receiving first chemotherapy
Eastern Cooperative Oncology group Performance Status is 0 to 2
Japanese ability to conversation, read and write
Key exclusion criteria
No consent is obtained to participate in the research.
There is psychiatric disorder.
There is leg injury or leg paralysis.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kojima |
Organization
Sapporo University of Health Sciences
Division name
Department of Nursing
Zip code
007-0894
Address
4-2 Nakanuma-Nishi, Higashi-ku, Sapporo
TEL
011-792-3350
e_kojima@sapporo-hokeniryou-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kojima |
Organization
Sapporo University of Health Sciences
Division name
Department of Nursing
Zip code
007-0894
Address
4-2 Nakanuma-Nishi, Higashi-ku, Sapporo
TEL
011-792-3350
Homepage URL
e_kojima@sapporo-hokeniryou-u.ac.jp
Sponsor or person
Institute
Sapporo University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Sapporo University of Health Sciences
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
Sapporo University of Health Sciences
Address
4-2 Nakanuma-Nishi, Higashi-ku, Sapporo
Tel
011-792-3350
e_kojima@sapporo-hokeniryou-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
| 2019 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000040630&t
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sapporo-hokeniryou-u.ac.jp/library/bulletin
Number of participants that the trial has enrolled
36
Results
A randomized controlled trial compared the intervention group who had taken a warm-water footbath and the control group. A two-way mixed analysis of variance was performed, and the result did not show significant differences the main effects of the intervention and the interaction effects. Significant differences were found in the main effect of time, the control group significantly worsened at overall fatigue scores after 6 days of chemotherapy, and at global qol scores after chemotherapy.
Results date posted
| 2023 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
non-small lung cancer patients undergoing first chemotherapy
Participant flow
The researcher explained the aim of this study to 43 participants. Informed consent was obtained from all participants, but 4 participants were excluded due to failure to meet criteria. 39 participants randomly assigned to intervention(n=20) and control groups(n=19). Finally, intervention(n=19) and control groups(n=17) were analyzed because 3 participants dropped out due to ill health.
Adverse events
nothing
Outcome measures
Cancer Fatigue Scale
Profile Mood States shortened version
OSA sleep inventory MA version
European Organization for Research and Treatment of Cancer-QLQ-C15PAL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040630
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/29 | 初回化学療法を受ける非小細胞肺がん患者に対する足浴ケアの倦怠感、気分、睡眠、およびQOL改善効果の検証_研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
