UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of intervention based care needs of breast cancer patients receiving adjuvant therapy
Title of the study (Brief title)	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	Tatsuo Akechi
Organization	Nagoya City University Medical School
Division name	Department of Psychiatry
Address	Kawasumi 1, mizuho-cho, mizuho-ku, Nagoya 467-8601
TEL
Email

Public contact
Name of contact person	Kanae Momino
Organization	Nagoya City University
Division name	School of Nursing
Address	Kawasumi 1, mizuho-cho, mizuho-ku, Nagoya 467-8601
TEL
Homepage URL
Email	momino@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001341