UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049657
Receipt number R000056551
Scientific Title Multidisciplinary Smartphone Support for reducing psychological distress and/or unmet needs among AYA cancer patients: A pilot randomized control trial
Date of disclosure of the study information 2022/12/01
Last modified on 2023/06/10 18:00:32

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Basic information

Public title

Multidisciplinary SMartphone Intervention for LEssening psychological distress and/or unmet needs among AYA cancer patients: A pilot randomized control trial

Acronym

SMILE AYA project

Scientific Title

Multidisciplinary Smartphone Support for reducing psychological distress and/or unmet needs among AYA cancer patients: A pilot randomized control trial

Scientific Title:Acronym

SMILE AYA project

Region

Japan


Condition

Condition

cancer

Classification by specialty

Breast surgery Pediatrics Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In this research, we will develop an innovative support method that makes full use of ICT so that multi-occupational services can be received with one access by smartphone without visiting the hospital. Specifically, the distress screening method developed in Japan and used in clinical settings (https://www.ncc.go.jp/jp/ncch/AYA/030/index.html) is used as an ePRO for smartphones. Based on the results, self-care information is provided, medical information including fertility is collected and provided through the website, and various difficulties in daily life are solved by themselves using smartphones. We will develop a mechanism to acquire skills, provide accurate information in social network services (SNS), and receive multi-professional support, and verify its usefulness in a randomized controlled trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Patient Health Questionnaire-9 (PHQ-9)

Key secondary outcomes

Generalized Anxiety Disorder-7 (GAD-7) , Short-form Supportive Care Needs Survey (SCNS-SF34), Fear of Cancer Recurrence Inventory-Short Form(FCRI-SF), Euro QOL 5D-5L(EQ-5D-5L), Satisfaction with intervention, unmet needs and distress screening


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

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

Smartphone Intervention

Interventions/Control_2

Usual treatment

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

15 years-old <=

Age-upper limit

39 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Having received a diagnosis of cancer (including non-epithelial malignant tumor)
2) Currently attending a pediatric, orthopedic, or mammary surgery outpatient clinic, and are not scheduled to be hospitalized for more than 3 days for examination or treatment due to diseases including cancer within the next 3 months
3) 15-39 years old at the time of obtaining consent (eConsent signing date)
(If under the age of 18, consent to participate in the research will be obtained from the person in charge of protection.)
4) Those who own and use smartphones on a daily basis and are able to answer the ePRO (electric Patient reported outcome) questionnaire

Key exclusion criteria

1) Those whose estimated prognosis is within 6 months
2) Currently visiting a psychiatrist or psychosomatic medicine department (follow-up by a palliative care team is acceptable)
3) Severe cognitive impairment or intellectual impairment (impairment of reading and writing)
4) Difficulty in reading and writing Japanese
5) When the researcher determines that participation in the study is inappropriate

Target sample size

20


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

Dept. of Psychiatry and Cognitive-Behavioral Medicine

Zip code

4678601

Address

Mizuho-cho, Mizuho-ku, Nagoya

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

Dept. of Psychiatry and Cognitive-Behavioral Medicine

Zip code

4678601

Address

Mizuho-cho, Mizuho-ku, Nagoya

TEL

052-853-8271

Homepage URL

https://smileaya-project.org

Email

takechi@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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

Nagoya City University Medical Research Ethics Review Committee

Address

Mizuho-cho, Mizuho-ku, Nagoya

Tel

052-858-7215

Email

clinical_research@med.nagoya-cu.ac.jp


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

名古屋市立大学病院、国立がん研究センター中央病院


Other administrative information

Date of disclosure of the study information

2022 Year 12 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

No longer recruiting

Date of protocol fixation

2022 Year 08 Month 30 Day

Date of IRB

2022 Year 11 Month 21 Day

Anticipated trial start date

2022 Year 12 Month 05 Day

Last follow-up date

2023 Year 05 Month 30 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 07 Month 30 Day

Date analysis concluded

2025 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2022 Year 12 Month 01 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=R000056551


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name