UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034218 |
|---|---|
| Receipt number | R000038996 |
| Scientific Title | A randomized controlled trial of the effect of RESPECT therapy for fertility preservation among young adult unmarried women with breast caner: REcovery and Shared-decision-making by Psychological Empowerment Counseling Team |
| Date of disclosure of the study information | 2018/09/20 |
| Last modified on | 2024/04/06 09:12:48 |
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Basic information
Public title
A randomized controlled trial of the effect of RESPECT therapy for fertility preservation among young adult unmarried women with breast caner: REcovery and Shared-decision-making by Psychological Empowerment Counseling Team
Acronym
RESPECT trial
Scientific Title
A randomized controlled trial of the effect of RESPECT therapy for fertility preservation among young adult unmarried women with breast caner: REcovery and Shared-decision-making by Psychological Empowerment Counseling Team
Scientific Title:Acronym
RESPECT trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the RESPECT therapy after diagnostic disclosure for cancer patients to the endpoints: 1) the primary endpoint; PTSD symptoms and distress, 2) the secondary endpoint; stress coping and adjustment to cancer, and 3) the secondary endpoint; decision conflict of fertility preservation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
PTSD symptoms (IES-R-J) at the time between after intervention and before cancer treatment
Key secondary outcomes
Mini Mental Adjustment to Cancer Scale (Mini-MAC) and Decisional Conflict Scale at the time between after intervention and before cancer treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A course (intervention group): participating in RESPECT therapy twice per 30 days before cancer treatment
Interventions/Control_2
B course (waiting control group): only participating in RESPECT therapy after cancer treatment
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Newly diagnosed non-metastatic breast cancer.
2) Women aged 20 to 39 years old.
3) Must be legally unmarried.
4) Must be the patients of Division of Breast Surgery, Department of Surgery, and/or Division of reproduction, Department of Obstetrics and Gynecology, which are in member of the RESPECT trials.
5) Must have at least 4 days between informed consent date and cancer treatment beginning date.
Key exclusion criteria
1) Refuse to sign the informed consent agreement.
2) Unable to fill in written questionnaires on their own (having severe physical incapacity, or psychiatric illnesses such as schizophrenia, or low literacy, or mental retardation).
3) Within three days between informed consent date and cancer treatment beginning date.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
044-977-8111
Homepage URL
nao@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae, Kawasaki City, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院（神奈川県）、聖マリアンナ医科大学附属ブレストアンドイメージング先端医療センター附属クリニック（神奈川県）、岐阜大学医学部附属病院（岐阜県）、聖路加国際病院（東京都）、亀田総合病院（千葉県）、埼玉医科大学総合医療センター（埼玉県）、獨協医科大学埼玉医療センター（埼玉県）、埼玉県立がんセンター（埼玉県）、がん研有明病院（東京都）、滋賀医科大学病院（滋賀県）、三重大学医学部附属病院（三重県）、栃木県立がんセンター（栃木県）、横浜労災病院（神奈川県）、横浜みなと赤十字病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 20 | 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
| 2018 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Period of Inclusion: 31-Mar-2025.
Management information
Registered date
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038996
