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 | 2024/06/02 09:22:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
None
Publication of results
Partially published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
10
Results
It is questionable whether the outcome data obtained were reliable due to many illogical points.
Results date posted
| 2024 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
AYA CANCER PATIENTS
Participant flow
Register and conduct application for 8 weeks
Adverse events
NONE
Outcome measures
FCRI-SF
Plan to share IPD
No plan
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
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056551
