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

May 10, 2024 updated by: Seoul National University Hospital

Scenario-based Clinical Interview Data Construction and User Experience Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bong-jin Hahm, M.D., Ph.D.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult cancer patients without severe cognitive decline

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Survey of unmet medical needs
20 people
User experience evaluation
40 people
Other: Interactive Artificial Intelligence
scenario based AI to assess, classify, explain and conduct supportive interviews
Clinical interview data collection
300 people

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Eulji University Hospital
Dongguk University Medical Center

Investigators

  • Principal Investigator: Bong-jin Hahm, M.D., Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HI23C0315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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