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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031140
Receipt No. R000035562
Scientific Title Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial
Date of disclosure of the study information 2018/03/01
Last modified on 2018/04/20

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Basic information
Public title Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial
Acronym SMILE project
Scientific Title Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial
Scientific Title:Acronym SMILE project
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate efficacy of smartphone-based behavioral activation and problem-solving treatment intervention to reduce fear of recurrence in breast cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Fear of recurrence: Japanese version of the Concerns About Recurrence Scale (CARS-J)
Key secondary outcomes 1.Fear of recurrence: Fear of Cancer Recurrence Inventory short form (FCRI-SF-J)
2. Psychological distress: Hospital Anxiety and Depression Scale (HADS)
3. Patients perceived needs: Short-form Supportive Care Needs Survey questionnaire (SCNS-SF34)
4. Posttraumatic Growth Inventory-Japanese (PTGI-J)
5. Level of satisfaction with treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention group: They start to use the smartphone-based problem-solving treatment program "Kaiketsu-App" for iPhones and iPads and the smartphone-based behavioral activation program the "Genki-App" for iPhones and iPads."Kaiketsu-App" consists of 7 sessions, including one introductory section, 4 sessions for learning PST 5 steps, 1 session for actual training, and one epilogue. The "Kaiketsu-App" can be completed within 4 weeks at the fastest. One session needs approximately 30 minutes to complete. "Genki-App" has been developed as a part of the smartphone-based CBT program "Kokoro-App" that was developed for our previous study."Genki-App" consists of 2 sessions.The "Genki-App" can be completed within between 2 weeks and 8 weeks and each session needs approximately 30 minutes per week to complete.
Interventions/Control_2 Waiting list control group: If the participant is allocated to the control group, she will be informed that the Kaiketsu and Genki-App can be resumed if the participant is willing to do so after week 8.
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) diagnosis of breast cancer and awareness of the cancer diagnosis
2) 1 year after breast surgery
3) currently disease-free
4) able to complete e-patient reported outcome (ePRO) by using iPhone
5) iPhone and/or iPad user and having apple ID to install application on Apple store
Key exclusion criteria 1) Having active and serious physical disease that disturb household and light work and current and past history of cancer other than breast cancer
2) Having serious psychiatric disease
3) an inability to understand Japanese
4) currently following up and getting treated in a psychiatry department and/or by any other mental health professionals
5) inappropriate to participate judged by researchers
6) patients who received structured problem-solving therapy, behavioral action therapy, and cognitive-behavioral therapy including participants into our previous study investigating the preliminary effectiveness of the smartphone-based problem-solving treatment
Target sample size 444

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Akechi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601 Japan
TEL 052-853-8271
Email takechi@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Akechi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601 Japan
TEL 052-853-8271
Homepage URL https://smile-project.org
Email takechi@med.nagoya-cu.ac.jp

Sponsor
Institute Japan Supportive, Palliative and Psychosocial Oncology Group
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 05 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035562

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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