UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of smartphone problem-solving therapy for fear of recurrence among breast cancer patients(Pilot Study)
Title of the study (Brief title)	Problem-solving therapy for breast cancer patients
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine preliminarily the effectiveness of smartphone problem-solving therapy for fear of recurrence among breast cancer patients
Basic objectives2	Others
Basic objectives -Others	To probe preliminarily the feasibility of smartphone problem-solving therapy for breast cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concerns About Recurrence Scale (CARS)
Key secondary outcomes	Hospital Anxiety and Depression Scale (HADS),EQ5D,FACIT-Sp-12,Short-form Supportive Care Needs Survey (SCNS-SF34),Social Problem-Solving Inventory-Revised(SPSI-R),Treatment 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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Smartphone problem-solving therapy
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	50 years-old >
Gender	Female
Key inclusion criteria	1)Patients with a diagnosis of invasive breast cancer(breast ductal carcinoma) 2)Patients who were disease-free survivors from 6 months after mastectomy or partial mastectomy 3)Patients whose performance status is 0-2 4)Patients who are smartfone users 5)Patients who hope to participate in this study 6)Patients who will not be hospitalized to a hospital for more than one month 7)Patients who are able to cooperate with additional telephone interviews for missing datum
Key exclusion criteria	1)Patients with too severe physical condition 2)Patients with too severe psychiatric condition 3)Inability to read and write Japanese 4)Patients receiving psychiatric treatment 5)Patients considered by their oncologists as inappropriateness of participation
Target sample size	38

Research contact person
Name of lead principal investigator	Fuminobu Imai
Organization	Nagoya city university graduate school of medical sciences
Division name	Department of psychiatry and cognitive-behavioral medicine
Address	1 kawasumi,mizuho-cho,mizuho-ku,nagoya 467-8601
TEL	052-853-8271
Email	bunshin0427@trad.ocn.ne.jp

Public contact
Name of contact person	Fuminobu Imai
Organization	Nagoya city university graduate school of medical sciences
Division name	Department of psychiatry and cognitive-behavioral medicine
Address	1 kawasumi,mizuho-cho,mizuho-ku,nagoya 467-8601
TEL	052-853-8271
Homepage URL
Email	bunshin0427@trad.ocn.ne.jp

Sponsor
Institute	Nagoya city university consultation-liaison psychiatry team
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 06 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 21 Day
Anticipated trial start date	2016 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 23 Day
Last modified on	2017 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025330