CancerNCT06415201
Interactive AI-based Mental Health Service for the Patients With Cancer
An observational study of Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Interactive Artificial Intelligence
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cancer patients without severe cognitive decline
Who may be able to join
- Patients diagnosed with malignant tumor and undergoing treatment, or patients undergoing follow-up after completing curative treatment
Who cannot join
- Patients unable to consent to research or be interviewed due to cognitive decline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bong-jin Hahm, M.D., Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 16801
Sunhyung Lee, M.D., 82-2-2072-3767, total3562@naver.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Interactive Artificial Intelligence
- Keywords
- mental health, distress, interactive artificial intelligence, virtual human
- Medical subject headings
- Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Artificial IntelligenceOther
scenario based AI to assess, classify, explain and conduct supportive interviews
| Study group | Role | What they receive |
|---|---|---|
| Survey of unmet medical needs | 20 people | |
| User experience evaluation | 40 people Receives: Other: Interactive Artificial Intelligence | |
| Clinical interview data collection | 200 people |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
Distress Thermometer
Measured: baseline
Quality of life measurement
The world health organization quality of life (WHOQOL)
Measured: baseline
Stress
Perceived Stress Scale (PSS-10)
Measured: baseline
Self-esteem
Korean version of Rosenberg Self-Esteem Scale (K-RES)
Measured: baseline
Acceptance of Disability
Acceptance of Disability Scale
Measured: baseline
Pain measurement
PBPI (Pain belief \& Perception inventory)
Measured: baseline
Insomnia
ISI (Insomnia Severity Index)
Measured: baseline
Quality of sleep
PSQI (Pittsburgh Sleep Quality Index)
Measured: baseline
Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)
Measured: baseline
Anxiety & Depression
HADS (Hospital anxiety and depression scale)
Measured: baseline
Fear of Disease Progression
FOP-SF (Fear of Disease Progression Short Form)
Measured: baseline
Social Support
MOS Social support Survey
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguk University Medical Center, Eulji University Hospital
- Responsible party
- Sponsor
- Investigators
- Bong-jin Hahm, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415201
- Sponsor's protocol ID
- HI23C0315
- Status last verified
- Oct 2024
- First submitted
- 10 May 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scenario-based Clinical Interview Data Construction and User Experience Evaluation
- ClinicalTrials.gov ID
- NCT06415201
- Acronym / sponsor ID
- HI23C0315
- Conditions
- Cancer
- Keywords
- mental health, distress, interactive artificial intelligence, virtual human
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dongguk University Medical Center, Eulji University Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Survey of unmet medical needs | – | –20 people |
| User experience evaluation | – | Other: Interactive Artificial Intelligence40 people |
| Clinical interview data collection | – | –200 people |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients without severe cognitive decline
Key inclusion criteria (1 listed)
- Patients diagnosed with malignant tumor and undergoing treatment, or patients undergoing follow-up after completing curative treatment
Key exclusion criteria (1 listed)
- Patients unable to consent to research or be interviewed due to cognitive decline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Artificial Intelligencescenario based AI to assess, classify, explain and conduct supportive interviews | Other | User experience evaluation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bong-jin Hahm, M.D., Ph.D. contact
Bong-jin Hahm, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunhyung Lee, M.D. (82-2-2072-3767, total3562@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.