NIPH Clinical Trials Search

AYATO-2

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	malignancy
Date of first enrollment	13/05/2026
Target sample size	280
Countries of recruitment
Study type	Interventional
Intervention(s)	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 response to the ST shows a DT score of 4 or higher or any checked item on the Problem List, an alert notification will be sent to the co-investigator. If support is judged necessary, the co-investigator will begin collecting information relevant to support within 2 weeks.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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.

Key inclusion & exclusion criteria

Age minimum	>= 15age old
Age maximum	<= 39age old
Gender	Both
Include 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.
Exclude 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.