UMIN-CTR Clinical Trial

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

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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 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


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

Completed

Date of protocol fixation

2018 Year 02 Month 07 Day

Date of IRB

2015 Year 07 Month 28 Day

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

2021 Year 10 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 05 Day

Last modified on

2022 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035562


Research Plan
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
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