UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016943 |
|---|---|
| Receipt number | R000019667 |
| Scientific Title | Feasibility of the self-care exercise program for patients with gynecologic cancer during chemotherapy |
| Date of disclosure of the study information | 2015/03/27 |
| Last modified on | 2015/03/27 15:45:50 |
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Basic information
Public title
Feasibility of the self-care exercise program for patients with gynecologic cancer during chemotherapy
Acronym
Feasibility of the self-care exercise program for patients with gynecologic cancer during chemotherapy
Scientific Title
Feasibility of the self-care exercise program for patients with gynecologic cancer during chemotherapy
Scientific Title:Acronym
Feasibility of the self-care exercise program for patients with gynecologic cancer during chemotherapy
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess feasibility of exercise program to maintain/improve QOL for cancer patients undergoing treatment based on program resulits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The MOS 8-Item Short-Form Health Survey(SF-8)
Key secondary outcomes
Hospital Anxiety and Depression Scale(HADS)
Thigh circumference measured
Tracking of exercise program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Implementetion Exercise Program
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patients with 25-65-year-old cancer going to hospital in therapeutic purpose of the chemotherapy
2) Performance status 0-2
3) No born metastasis
4) No physical suffer (dyspnea,pain,edema) no mentalfatigue,docter and nurses permit to attend the program
5) Patient who can communicate others and record a diary
6)No visual impairment
Key exclusion criteria
1) Performance status 3-4
2) Patient has born metastasis
3) Patient has physical suffer
4) Patient has mental fatigue
5) Docter and nurse do not permit to attend the program
6) Patient who can not communicate others and record a diary
7)Patienr who exeperience this program,before
8)Patients remeining days are less than 6 month
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | chaen mika |
Organization
Keio University
Division name
Faculty of nursing and medical care
Zip code
Address
35 Shinanomachi Shinjyuku-ku ,Tokyo
TEL
03-5363-2084
cmika@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | chaen mika |
Organization
Keio University
Division name
Faculty of nursing and medical care
Zip code
Address
35 Shinanomachi Shinjyuku-ku ,Tokyo
TEL
03-5363-2084
Homepage URL
cmika@sfc.keio.ac.jp
Sponsor or person
Institute
Exercise Program for Cancer Patient in Keio Unversity
Institute
Department
Personal name
Funding Source
Organization
Keio gijuku academie deveropment funds
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
Address
Tel
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
| 2015 | Year | 03 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2015 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019667
