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UMIN-CTR Clinical Trial |
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Name: | 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 |
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) | |
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Condition | ||
Condition | Breast cancer | |
Classification by specialty |
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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 |
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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. | |
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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) |
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Target sample size | 74 |
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Name of lead principal investigator |
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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 | ||||||
nao@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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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