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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017754
Receipt No. R000020564
Scientific Title Development of a psychological support system for fertility preservation aimed at improving young cancer patient survivorship
Date of disclosure of the study information 2015/06/01
Last modified on 2017/12/01

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Basic information
Public title Development of a psychological support system for fertility preservation aimed at improving young cancer patient survivorship
Acronym RCT study of Oncofertlity! Psycho-Education And Couple Enrichment (O!PEACE) therapy for young breast cancer patients and their husbands (The RCT study of O!PEACE therapy)
Scientific Title Development of a psychological support system for fertility preservation aimed at improving young cancer patient survivorship
Scientific Title:Acronym RCT study of Oncofertlity! Psycho-Education And Couple Enrichment (O!PEACE) therapy for young breast cancer patients and their husbands (The RCT study of O!PEACE therapy)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the improvement of mental health by the couple psycho-education program, O!PEACE (Oncofertility! Psycho-Education And Couple Enrichment therapy) after diagnostic disclosure for cancer patients, based on three criteria: 1) the psychological health status of each partner, 2) the psychological resilience of each partner according to their mental and behavioral adaptability, 3) communication between the spouses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes The mental health of both spouses (IES-R, K6, HADS)
Key secondary outcomes The mental resilience of each partner according the their mental and behavioral adaptability (TAC-24, CD-RISC), communication between the spouses (Scale of Relationship-Focused coping)

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Conduct psycho-education program face-to-face using the O!PEACE booklets and answer questionnaires twice before the initiation of cancer treatment.
Interventions/Control_2 Distribute the booklets about oncofertility as usual care and answer questionnaires twice before the initiation of 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

Not applicable
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria 1) Must be the patients of Division of Breast Surgery, Department of Surgery, St. Marianna University School of Medicine Hospital, The Jikei University hospital, Kameda Medical Center, Saitama Medical Center, Saitama Medical University, Gifu University Hospital, Saitama Cancer Center, St Luke's International Hospital and Cancer Institute Hospital.
2) Under 39 years of age
3) Newly diagnosed non-metastatic breast cancer
4) Must be legally married



Key exclusion criteria 1) Failed 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)
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nao Suzuki
Organization St. Marianna University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
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
Middle name
Last name Nao Suzuki
Organization St. Marianna University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)
St. Marianna University School of Medicine Hospital(Kanagawa)、
東京慈恵会医科大学附属病院(東京都)
The Jikei University Hospital(Tokyo)、
亀田総合病院(千葉県)
Kameda Medical Center(Chiba)、
埼玉医科大学 総合医療センター(埼玉県)
Saitama Medical Center, Saitama Medical University(Saitama)、
岐阜大学医学部附属病院(岐阜県)
Gifu University Hospital(Gifu)、
埼玉県立がんセンター(埼玉県)
Saitama Cancer Center(Saitama)、
聖路加国際病院(東京都)
St Luke's International Hospital(Tokyo)、
がん研有明病院(東京都)
Cancer Institute Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 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
2015 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 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 05 Month 31 Day
Last modified on
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020564

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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