NCT06415201

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2024Dec 2027

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

June 25, 2025

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

May 10, 2024

Last Update Submit

June 19, 2025

Conditions

Keywords

mental healthdistressinteractive artificial intelligencevirtual human

Outcome Measures

Primary Outcomes (12)

  • Distress

    Distress Thermometer

    baseline

  • Quality of life measurement

    The world health organization quality of life (WHOQOL)

    baseline

  • Stress

    Perceived Stress Scale (PSS-10)

    baseline

  • Self-esteem

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

    baseline

  • Acceptance of Disability

    Acceptance of Disability Scale

    baseline

  • Pain measurement

    PBPI (Pain belief \& Perception inventory)

    baseline

  • Insomnia

    ISI (Insomnia Severity Index)

    baseline

  • Quality of sleep

    PSQI (Pittsburgh Sleep Quality Index)

    baseline

  • Fatigue

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

    baseline

  • Anxiety & Depression

    HADS (Hospital anxiety and depression scale)

    baseline

  • Fear of Disease Progression

    FOP-SF (Fear of Disease Progression Short Form)

    baseline

  • Social Support

    MOS Social support Survey

    baseline

Study Arms (3)

Survey of unmet medical needs

20 people

User experience evaluation

40 people

Other: Interactive Artificial Intelligence

Clinical interview data collection

200 people

Interventions

scenario based AI to assess, classify, explain and conduct supportive interviews

User experience evaluation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult cancer patients without severe cognitive decline

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 16801, South Korea

RECRUITING

MeSH Terms

Conditions

NeoplasmsPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Bong-jin Hahm, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunhyung Lee, M.D.

CONTACT

Bong-jin Hahm, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

March 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

June 25, 2025

Record last verified: 2024-10

Locations