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Clinical Trials/NCT06415201
NCT06415201
Recruiting
Not Applicable

Scenario-based Clinical Interview Data Construction and User Experience Evaluation

Seoul National University Hospital1 site in 1 country260 target enrollmentMarch 1, 2024
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Seoul National University Hospital
Enrollment
260
Locations
1
Primary Endpoint
Distress
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
December 31, 2027
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Distress

Time Frame: baseline

Distress Thermometer

Quality of life measurement

Time Frame: baseline

The world health organization quality of life (WHOQOL)

Stress

Time Frame: baseline

Perceived Stress Scale (PSS-10)

Self-esteem

Time Frame: baseline

Korean version of Rosenberg Self-Esteem Scale (K-RES)

Acceptance of Disability

Time Frame: baseline

Acceptance of Disability Scale

Pain measurement

Time Frame: baseline

PBPI (Pain belief \& Perception inventory)

Insomnia

Time Frame: baseline

ISI (Insomnia Severity Index)

Quality of sleep

Time Frame: baseline

PSQI (Pittsburgh Sleep Quality Index)

Fatigue

Time Frame: baseline

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)

Anxiety & Depression

Time Frame: baseline

HADS (Hospital anxiety and depression scale)

Fear of Disease Progression

Time Frame: baseline

FOP-SF (Fear of Disease Progression Short Form)

Social Support

Time Frame: baseline

MOS Social support Survey

Study Sites (1)

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