UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051805 |
|---|---|
| Receipt number | R000059097 |
| Scientific Title | Yoga and Cognitive Behavior Therapy Based Program to Promote Transition in Gynecologic Cancer Survivors - a Feasibility Study |
| Date of disclosure of the study information | 2023/08/04 |
| Last modified on | 2024/02/01 10:34:56 |
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Basic information
Public title
Yoga and Cognitive Behavior Therapy Based Program to Promote Transition in Gynecologic Cancer Survivors - a Feasibility Study
Acronym
Yoga and Cognitive Behavioral Therapy Program for Gynecologic Cancer Survivors
Scientific Title
Yoga and Cognitive Behavior Therapy Based Program to Promote Transition in Gynecologic Cancer Survivors - a Feasibility Study
Scientific Title:Acronym
Yoga and Cognitive Behavioral Therapy Program for Gynecologic Cancer Survivors
Region
| Japan |
Condition
Condition
Gynecological cancer (Uterine cancer, Cervical cancer, Uterine sarcoma, Ovarian cancer, Choriocarcinoma)
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to examine the feasibility of a program combining yoga and cognitive behavioral therapy to assist gynecologic cancer survivors in facilitating the
process of Transition.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Program participation rates
Key secondary outcomes
1. Simplified menopausal index
2. Cancer Concerns Checklist
3. Sense of Coherence-13
4. General Health Questionnaire-12
5. Salivary Cortisol
6. Heart rate, HF/LF
7. Blood pressure
8. Program acceptability
9. Adverse events
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
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
120-minute programs (50 minutes of yoga and 70 minutes of cognitive behavioral therapy), once a week for 8 weeks.
Interventions/Control_2
Live life as usual.
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
Female
Key inclusion criteria
1. Diagnosis of gynecological cancer
2. Age 20 or older at diagnosis
3. At least 2 months after surgery or completion of postoperative adjuvant therapy
4. Performance Status 0 or 1 at the time of the survey
5. No recurrence or metastasis
6. Able to perform light exercise
Key exclusion criteria
1. Do not understand written or spoken Japanese
2. Diagnosis of mental disorder or cognitive impairment
3. Received yoga therapy or cognitive behavioral therapy
4. Plans to participate in other intervention study with gynecological cancer survivors in the near future
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Ishiguro |
Organization
Japanese Red Cross Toyota College of Nursing
Division name
Medical Surgical Nursing
Zip code
471-8565
Address
12-33 Nanamagari, Hakusan-cho, Toyota, Aichi, Japan
TEL
0565-36-5111
c-ishiguro@rctoyota.ac.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Ishiguro |
Organization
Japanese Red Cross Toyota College of Nursing
Division name
Medical Surgical Nursing
Zip code
471-8565
Address
12-33 Nanamagari, Hakusan-cho, Toyota, Aichi, Japan
TEL
0565-36-5111
Homepage URL
c-ishiguro@rctoyota.ac.jp
Sponsor or person
Institute
Japanese Red Cross Toyota College of Nursing
Institute
Department
Personal name
Chieko Ishiguro
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology(MEXT)
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Japanese Red Cross Toyota College of Nursing
Address
12-33 Nanamagari, Hakusan-cho, Toyota, Aichi, Japan
Tel
0565-36-5111
gakumu@rctoyota.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
日本赤十字豊田看護大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 03 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059097
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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