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

Cancer Clinical Trial

Official title:

Scenario-based Clinical Interview Data Construction and User Experience Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415201
• Other study ID #: HI23C0315
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: Sunhyung Lee, M.D.
• Phone: 82-2-2072-3767
• Email: total3562[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Interactive Artificial Intelligence
scenario based AI to assess, classify, explain and conduct supportive interviews

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dongguk University Medical Center, Eulji University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress	Distress Thermometer	baseline
Primary	Quality of life measurement	WHOQOL	baseline
Primary	Stress	PSS-10 (Perceived Stress Scale)	baseline
Primary	Self-esteem	K-RES (Korean version of Rosenberg Self-Esteem Scale)	baseline
Primary	Acceptance of Disability	Acceptance of Disability Scale	baseline
Primary	Pain measurement	PBPI (Pain belief & Perception inventory)	baseline
Primary	Insomnia	ISI (Insomnia Severity Index)	baseline
Primary	Quality of sleep	PSQI (Pittsburgh Sleep Quality Index)	baseline
Primary	Fatigue	FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy)	baseline
Primary	Anxiety & Depression	HADS (Hospital anxiety and depression scale)	baseline
Primary	Suicidality	MINI-Plus (Mini-international Neuropsychiatric interview)	baseline
Primary	Fear of Disease Progression	FOP-SF (Fear of Disease Progression Short Form)	baseline
Primary	Social Support	MOS Social support Survey	baseline