Interactive AI-based Mental Health Service for the Patients With Cancer

Recruiting

• Conditions: Cancer

• Registration Number: NCT06415201
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The aims of this study are developments of mental health care services for cancer patients based on interactive artificial intelligence. To do these things, survey of unmet medical needs and data collection of clinical interviews will be done, and newly developed assessment and intervention scenarios will be simulated to cancer patients group.

Detailed Description

A total of 20 people will be recruited from 3 institutions to investigate unmet medical needs. Based on the needs, we will develop scenarios to assess, classify, explain and conduct supportive interviews. We plan to develop a stress self-management scenario that helps manage lifestyle habits and provides meditation-based cognitive therapy. For moderate to severe distress, we plan to develop scenarios to link medical care and manage suicide risk. We plan to conduct interviews with a total of 300 people to collect clinical interview data for scenario development.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Patients diagnosed with malignant tumor and undergoing treatment, or patients undergoing follow-up after completing curative treatment

Exclusion Criteria

• Patients unable to consent to research or be interviewed due to cognitive decline

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measurement	baseline	The world health organization quality of life (WHOQOL)
Stress	baseline	Perceived Stress Scale (PSS-10)
Self-esteem	baseline	Korean version of Rosenberg Self-Esteem Scale (K-RES)
Acceptance of Disability	baseline	Acceptance of Disability Scale
Pain measurement	baseline	PBPI (Pain belief \& Perception inventory)
Insomnia	baseline	ISI (Insomnia Severity Index)
Quality of sleep	baseline	PSQI (Pittsburgh Sleep Quality Index)
Fatigue	baseline	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
Anxiety & Depression	baseline	HADS (Hospital anxiety and depression scale)
Fear of Disease Progression	baseline	FOP-SF (Fear of Disease Progression Short Form)
Social Support	baseline	MOS Social support Survey
Distress	baseline	Distress Thermometer

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of