Skip to content

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

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 - SMILE AYA PROJECT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054583
Enrollment
224
Registered
2024-06-06
Start date
2024-06-03
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

Distress screening-based information provision Participants&#39
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 c
(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 wa

Sponsors

Nagoya City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactYoshihiko Harada

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

yharada.psychfl@gmail.com+81-52-853-8271

Outcome results

None listed

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