UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054583 |
|---|---|
| Receipt number | R000062047 |
| Scientific Title | Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized muti-center randomized controlled clinical trial |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2025/12/08 16:42:10 |
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Basic information
Public title
Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized muti-center randomized controlled clinical trial
Acronym
SMILE AYA PROJECT
Scientific Title
Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized muti-center randomized controlled clinical trial
Scientific Title:Acronym
SMILE AYA PROJECT
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of distress screening-based information provision and smartphone problem-solving therapy for psychological distress including fear of recurrence and depression in AYA cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
Key secondary outcomes
Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), UCLA Loneliness Scale version 3 Japanese version short form (UCLA-LS3-J-SF), Brief Resilience Scale Japanese version (BRS-J), Euro QOL 5D-5L (EQ-5D-5L)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Distress screening-based information provision
Participants' distress and supportive care needs will be screened by smartphone-based Japanese version of the Distress Thermometer and Problem List (DTPL-J) at week 0 and 4. DTPL-J consist of 49 items including 5 categories (physical problems, Family problems, Practical problems, Emotional problem, and Spiritual or Religious problems) and its validity and reliability was confirmed. Based on the screening, the participants will be automatically directed to the website of a public medical institution that provides appropriate information and self-care skills that help to ameliorate its distress and needs. If there will no appropriate website, the multidisciplinary research teams compensate for these information.
Interventions/Control_2
Smartphone-based Problem solving therapy (PST)
PST provides patients with a structured, five-step strategy for solving their problems: (1) identification, definition, and breakdown of the problem; (2) establishing achievable goals; (3) generating solutions; (4) evaluating and choosing the solution; and (5) implementing the chosen solution and evaluating the outcome after implementation. The smartphone-based PST program (Life2Bits Inc., Japan) was developed for this study. The app development was based on our empirically supported PST manual. The app comprise nine sessions. Each session takes approximately 10 minutes to complete.
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
Patients who meet all the following criteria are eligible:
(1) The patient has been notified of a diagnosis of cancer (including non-epithelial malignancies).
(2) Is an outpatient and is not scheduled to be hospitalized for more than 3 days for cancer within the next 3 months.
(3) The patient is between 15-39 years old at the time of consent (date of e-Consent signature). (If the patient is under 18 years of age, consent for participation in the study must be obtained from a parent or guardian.)
(4) Own and use a smartphone on a daily basis and are able to answer the electric Patient Reported Outcome (e-PRO) questionnaire.
Key exclusion criteria
(1) Estimated prognosis is within 6 months.
(2) Currently attending psychiatry or psychosomatic medicine. (Follow-up by the palliative care team is acceptable.)
(3) Patients with psychiatric symptoms that the physician deems inappropriate for participation, such as dementia, cognitive dysfunction, or severe depression with thoughts of death.
(4) Difficulty in reading and writing Japanese.
(5) Have participated in cognitive-behavioral therapy, including smartphone-based therapy (e.g., our previous studies; Smile Project, Smile Again Project, or Sakura Project).
(6) The investigator determines that the patient is not suitable to participate in the study.
Target sample size
224
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
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
+81-52-853-8271
takechi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Harada |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
+81-52-853-8271
Homepage URL
yharada.psychfl@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
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
Clinical Research Management Center, Nagoya City University Hospital
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
+81-52-851-5511
irb_jimu@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062047
