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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name