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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049657
Enrollment
20
Registered
2022-12-01
Start date
2022-12-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

Smartphone Intervention Usual treatment

Sponsors

Nagoya City University Graduate School of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Patient Health Questionnaire-9 (PHQ-9)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTatsuo Akechi

Nagoya City University Graduate School of Medical Sciences Dept. of Psychiatry and Cognitive-Behavioral Medicine

takechi@med.nagoya-cu.ac.jp052-853-8271

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026