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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034218
Receipt No. 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 2019/06/17

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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
Email 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
Email nao@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email kenkyu@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)、

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
Anticipated trial start date
2018 Year 09 Month 20 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
2018 Year 09 Month 20 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038996

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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