UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001108 |
|---|---|
| Receipt number | R000001341 |
| Scientific Title | Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy |
| Date of disclosure of the study information | 2008/04/03 |
| Last modified on | 2017/06/22 20:25:48 |
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Basic information
Public title
Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy
Acronym
Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy
Scientific Title
Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy
Scientific Title:Acronym
Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy
Region
| Japan |
Condition
Condition
Breast cancer patients receiving postoperative adjuvant therapy
Classification by specialty
| Breast surgery | Psychiatry | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of comprehensive intervention based individual care needs with breast cancer patients experiencing psychosocial distress, and to identify the effectiveness of the intervention program for them preliminarily
Basic objectives2
Others
Basic objectives -Others
Feasibility/effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Profile of Mood States (POMS)
Key secondary outcomes
1.The short-form Supportive Care Needs Survey (SCNS-SF34)
2.European Organization for Research and Treatment of Cancer QLQ-C30(EORTC QLQC-30)
3.The Concerns About Recurrence Scale (CARS)
4.Patient Satisfaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1.Patient's care needs identification
2.Brief Problem-Solving Therapy (4 sessions during 2 months)
3.Information giving
4.Care coordination
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Being identified invasive ductal carcinoma of the breast histologically
2.Having no distant metastasis
3.Being 3 months or more and less than six months from the surgery
4.Receiving a score of 0 to 2 on the European Organization for Research and Treatment of Cancer-Performance Status (ECOG-PS)
5.Being 20 years of age or older
6.Meeting the screening criteria for psychological distress
Key exclusion criteria
1.too physically and mentally ill to complete a self-reported questionnaire and the intervention
2.Having cognitive impairment
3.Being unable to read and write Japanese
4.Being Considered by the oncologist to be unable to participate the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Akechi |
Organization
Nagoya City University Medical School
Division name
Department of Psychiatry
Zip code
Address
Kawasumi 1, mizuho-cho, mizuho-ku, Nagoya 467-8601
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanae Momino |
Organization
Nagoya City University
Division name
School of Nursing
Zip code
Address
Kawasumi 1, mizuho-cho, mizuho-ku, Nagoya 467-8601
TEL
Homepage URL
momino@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2007 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 03 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001341
