UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041536 |
|---|---|
| Receipt number | R000047301 |
| Scientific Title | Optimizing smartphone psychotherapy for depression and anxiety among patients with cancer: multiphase optimization strategy [MOST] by using innovative clinical trial system |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/06/10 18:01:39 |
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Basic information
Public title
SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience for cancer patients: SMILE AGAIN project
Acronym
SMILE AGAIN project
Scientific Title
Optimizing smartphone psychotherapy for depression and anxiety among patients with cancer: multiphase optimization strategy [MOST] by using innovative clinical trial system
Scientific Title:Acronym
Optimizing smartphone psychotherapy for depression and anxiety among patients with cancer
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Oto-rhino-laryngology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine specific efficacy of CBT components, thereby determining the most effective and efficient combination for depression and anxiety of cancer patients to improve their quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
the change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to 8 weeks later
Key secondary outcomes
the change in Generalized Anxiety Disorder-7 (GAD-7) total score from baseline to 8 weeks later
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Smartphone Psycho-therapy <Patient Education:PE+Problem Solving; PS+Behavioral Activation; BA+Assertion Training; AT>
Interventions/Control_2
Smartphone Psycho-therapy(PE+BA+PS+AT)
Interventions/Control_3
Smartphone Psycho-therapy(PE+PS+BA)
Interventions/Control_4
Smartphone Psycho-therapy(PE+BA+PS)
Interventions/Control_5
Smartphone Psycho-therapy(PE+AT+PS)
Interventions/Control_6
Smartphone Psycho-therapy(PE+PS+AT)
Interventions/Control_7
Smartphone Psycho-therapy(PE+AT+BA)
Interventions/Control_8
Smartphone Psycho-therapy(PE+BA+AT)
Interventions/Control_9
Smartphone Psycho-therapy(PE+PS)
Interventions/Control_10
Smartphone Psycho-therapy(PE+PS)
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. diagnosis of cancer and awareness of the cancer diagnosis
2. an age of 20 years or older
3. being a smartphone user and able to complete an electronic patient-reported outcome (e-PRO) using an smartphone
4. estimated prognosis is more than six months
5. who are expected to be able to concentrate on intervention for about two months after participation of this study (e.g. who doesn't plan to use cell-killing anticancer drug with strong side effect)
Key exclusion criteria
1. patients who did not understand the Japanese language;2. patients whom attending physicians recognized as inappropriate by psychiatric symptom (e.g. dementia, cognitive impairment and severe depression with suicide ideation)
3. patients who had received cognitive behavioral therapy 4. patients who had received smartphone cognitive behavioral therapy or participated on our previous study
Target sample size
352
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Akechi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
4678601
Address
Kawasumi 1 Mizuho-cho Mizuho-ku Nagoya Aichi JAPAN
TEL
052-853-8271
takechi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Akechi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
4678601
Address
Kawasumi 1 Mizuho-cho Mizuho-ku Nagoya Aichi JAPAN
TEL
052-853-8271
Homepage URL
http://smileagain-project.org
info@smileagain-project.org
Sponsor or person
Institute
Japan Supportive, Palliative and Psychosocial Oncology Group
Institute
Department
Personal name
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
IRB of Nagoya City University Graduate School of Medicine and Nagoya City University Hospital
Address
Kawasumi 1 Mizuho-cho Mizuho-ku Nagoya Aichi JAPAN
Tel
052-851-5511
clinical_research@med.nagoya-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
U1111-1272-3021
Org. issuing International ID_1
WHO ICRTP
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知県がんセンター（愛知県）、国立がん研究センター東病院（千葉県）、東北大学病院（宮城県）、静岡県立静岡がんセンター（静岡県）、国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Intervention/Control_11: Smartphone Psycho-therapy(PE+BA)
Intervention/Control_12: Smartphone Psycho-therapy(PE+BA)
Intervention/Control_13: Smartphone Psycho-therapy(PE+AT)
Intervention/Control_14: Smartphone Psycho-therapy(PE+AT)
Intervention/Control_15: Smartphone Psycho-therapy(PE)
Intervention/Control_16: Smartphone Psycho-therapy(PE)
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047301
