UMIN-CTR Clinical Trial

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

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IRB Contact (For public release)
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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
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Results
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Baseline Characteristics
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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
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Research case data
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