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AYATO-2

A Multicenter Prospective Randomized Controlled Trial of Mobile App Based Distress Screening With Proactive Multidisciplinary Support for Adolescent and Young Adult Cancer Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030260107
Enrollment
280
Registered
2026-05-13
Start date
2026-05-13
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

malignancy Adolescent and Young Adult, AYAs, Cancer, screening, supportive care

Interventions

For 3 months after enrollment, participants in the intervention group will receive the screening tool (ST) via the app on their mobile device once monthly, for a total of 3 administrations. If the res

Sponsors

Ishiki Hiroto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients meeting all of the following criteria will be eligible for inclusion in this study. 1) Individuals who have been diagnosed with cancer (including hematologic malignancies) and are scheduled to begin their initial cancer treatment. (2) Individuals aged 15 years, or 16-39 years, who are judged by the attending physician to have the capacity to provide consent, (3) newly diagnosed with a malignant tumor and with no prior treatment history for that cancer or recurrence for the first time after completion of curative treatment(4) Individuals who own a mobile phone (smartphone) and are able to operate the application used in this study(5) Patients from whom written informed consent for study participation has been obtained, for patients younger than 18 years, consent for study participation must also be obtained from a legally authorized representative.

Exclusion criteria

Exclusion criteria: Exclusion criteria- Patients meeting any of the following criteria will be excluded. (1) Patients with severe cognitive impairment, such as delirium or cognitive dysfunction; (2) Patients with difficulty reading or writing Japanese; (3) Patients who are enrolled in another interventional study for which the intervention in this study would be undesirable; (4) Patients whom the attending physician otherwise considers unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Primary endpoint of the trial will be proportion of all enrolled patients with a Distress Thermometer(DT) score >=4 at 3 months.

Secondary

MeasureTime frame
The secondary endpoints will be changes from enrollment to 3 months in DT scores and in the number of checked items on the Problem List, quality of life (QOL) measured by EORTC QLQ-C30 and EORTC QLQ-AYA30, the proportion of participants with distress at 3 months (DT score 4 or higher or any checked Problem List item), the types of AYA support team interventions provided during the 3 months after enrollment, and the usefulness of the screening tool, app, and online consultation, Implementation feasibility of the screening tool, app, and online consultation, Time from a request for support to resolution of the problem, Implementation feasibility of the screening tool, app, and online consultation.

Contacts

Public ContactEriko Satomi

National Cancer Center Hospital Japan

CRL_office@ml.res.ncc.go.jp+81-335475201

Outcome results

None listed

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