Unique ID issued by UMIN | UMIN000031140 |
---|---|
Receipt number | 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 | 2022/04/26 18:30:15 |
Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial
SMILE project
Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial
SMILE project
Japan |
breast cancer
Breast surgery |
Malignancy
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
Fear of recurrence: Japanese version of the Concerns About Recurrence Scale (CARS-J)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
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.
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.
20 | years-old | <= |
50 | years-old | > |
Female
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
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
444
1st name | |
Middle name | |
Last name | Tatsuo Akechi |
Nagoya City University Graduate School of Medical Sciences
Department of Psychiatry and Cognitive-Behavioral Medicine
Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601 Japan
052-853-8271
takechi@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Tatsuo Akechi |
Nagoya City University Graduate School of Medical Sciences
Department of Psychiatry and Cognitive-Behavioral Medicine
Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467-8601 Japan
052-853-8271
https://smile-project.org
takechi@med.nagoya-cu.ac.jp
Japan Supportive, Palliative and Psychosocial Oncology Group
Japan Agency for Medical Research and Development
Japanese Governmental office
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 07 | Day |
2015 | Year | 07 | Month | 28 | Day |
2018 | Year | 03 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 10 | Month | 31 | Day |
2018 | Year | 02 | Month | 05 | Day |
2022 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035562
Research Plan | |
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Registered date | File name |
2022/04/26 | ★20180305SMILE PROJECT プロトコルver4.1-JSUPPORT提出用(IRBコメ)明智.docx |
Research case data specifications | |
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Registered date | File name |
2022/04/26 | SMILE_データセット仕様書.xlsx |
Research case data | |
---|---|
Registered date | File name |
2022/04/26 | SMILE_データセット仕様書.xlsx |