UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053068 |
|---|---|
| Receipt number | R000060555 |
| Scientific Title | Study of the utility of a new community cancer salon (Gan-Labo) using a living lab. |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2023/12/12 12:26:44 |
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Basic information
Public title
Study of the utility of a new community cancer salon (Gan-Labo) using a living lab.
Acronym
Utility of a New Community Cancer Salon'Gan-Labo'
Scientific Title
Study of the utility of a new community cancer salon (Gan-Labo) using a living lab.
Scientific Title:Acronym
Utility of a New Community Cancer Salon'Gan-Labo'
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the utility of a cancer lab that incorporates a cancer cafe, cancer salon, biometric measurements, and living lab approach, as it may contribute to maintaining and improving the quality of life of cancer survivors. The purpose of the study is also to examine the effects of physical and mental changes in gait, body balance, body composition, etc., and their influence on QOL by providing a baseline of physical and activity measurements such as gait, body balance, body composition, etc., and psychological checkups before the start of the cancer lab, as well as learning opportunities about exercise, nutrition, relaxation, and the latest information on breast cancer treatment. The purpose of this study is to examine the impact of these changes on quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
WHO-QOL26score
Key secondary outcomes
1. Questionnaire on the usefulness of the cancer lab
2. Anthropometric data: body composition and muscle mass, brachial circumference, grip strength, blood pressure, heart rate, finger pulse wave, height.
3.Activity measurement data: gait measurement (walking posture, walking speed), number of steps, activity level, standing balance measurement
4.Facial expression measurement data: facial images (44 facial muscle movements)
5.Subjective questionnaire: free description of pain/symptoms/feelings, bowel movements, sleep, appetite, fatigue, mood, exercise habits, history of falls, and any inconvenience in life, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Four-month participation in a Gan-Labo
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Must be a first-time breast cancer survivor between the ages of 20 and 79 years old who attends Niigata Breast Clinic in Japan.
Must be judged by the attending physician to have completed treatment and to be in stable condition (including those undergoing hormone therapy).
Must be willing to participate in the Cancer Lab once a month for at least 4 consecutive months for at least 1 year.
Key exclusion criteria
Patients with recurrent or local recurrence.
Patients with bilateral breast cancer.
Patients scheduled for breast reconstruction.
Patients undergoing molecular targeted therapy.
Participants who fail to participate in the study for more than 4 months will be considered as dropouts. Participants who fail to participate for more than 4 months will be considered to have dropped out of the study. In addition, those who failed to complete or had many missing items on the three questionnaires or those who left before or during the cancer lab and were unable to complete the questionnaires will also be considered as dropouts. Data from individuals who are cognitively impaired and unable to complete the questionnaires on their own will also be excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
46 Asahimachi dori2, Chuo-ku, Niigata city, Niigata Prefecture
TEL
+81252270941
sakai@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
746 Asahimachi dori2, Chuo-ku, Niigata city, Niigata Prefecture
TEL
+81252270941
Homepage URL
sakai@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan society the promotion of science, Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
757 Ichibancho, Asahimachi-dori, Chuo Ward, Niigata City 951-8510
Tel
+8525-227-2625
ethics@adm.niigata-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
| 2023 | Year | 12 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060555
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