UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017754 |
|---|---|
| Receipt number | 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 09:55:30 |
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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
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
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020564
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