UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028515 |
|---|---|
| Receipt number | R000005172 |
| Scientific Title | Collaborative care to reduce perceived needs in highly distressed breast cancer patients: Randomized controlled trial |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2017/08/08 07:53:52 |
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Basic information
Public title
Collaborative care to reduce perceived needs in highly distressed breast cancer patients: Randomized controlled trial
Acronym
Collaborative care to reduce perceived needs in highly distressed breast cancer patients: Randomized controlled trial
Scientific Title
Collaborative care to reduce perceived needs in highly distressed breast cancer patients: Randomized controlled trial
Scientific Title:Acronym
Collaborative care to reduce perceived needs in highly distressed breast cancer patients: Randomized controlled trial
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of a collaborative care intervention among patients with breast cancer for their unmet care needs and distress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The short-form Supportive Care Needs Survey (SCNS-SF34)
Key secondary outcomes
Profile of Mood States (POMS)
European Organization for Research and Treatment of Cancer QLQ-C30(EORTC QLQC-30)
The Concerns About Recurrence Scale (CARS)
Patient Satisfaction for the providing treatment and supportive care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Brief Problem-Solving Therapy (total four sessions), Information service and care management
Interventions/Control_2
Usual Care
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
Being identified invasive ductal carcinoma of the breast histologically
1 Having no distant metastasis
2 Being 3 months or more and less than six months from the surgery
3 Receiving a score of 0 to 2 on the European Organization for Research and Treatment of Cancer-Performance Status (ECOG-PS)
4 Being 20 years of age or older
5 Meeting the screening criteria for psychological distress
Key exclusion criteria
1.Being 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
60
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
052-853-8271
takechi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 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
052-853-8271
Homepage URL
takechi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
Nagoya City University Hospital (Aichi)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 03 | Day |
Last modified on
| 2017 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005172
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
