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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028515
Receipt No. 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

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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
Last 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
Email takechi@med.nagoya-cu.ac.jp

Public contact
1st 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
Email takechi@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005172

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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