## Protocol Section
### Identification Module
**NCT ID:** NCT06415201

**Brief Title:** Interactive AI-based Mental Health Service for the Patients With Cancer

**Official Title:** Scenario-based Clinical Interview Data Construction and User Experience Evaluation

#### Organization Study ID Info
**ID:** HI23C0315
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Dongguk University Medical Center

**Class:** OTHER

**Name:** Eulji University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cancer

**Keywords:**

- mental health

- distress

- interactive artificial intelligence

- virtual human

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 360

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 20 people

**Label:** Survey of unmet medical needs

#### Arm Group 2

**Description:** 40 people

**Intervention Names:**

- Other: Interactive Artificial Intelligence

**Label:** User experience evaluation

#### Arm Group 3

**Description:** 300 people

**Label:** Clinical interview data collection

### Interventions

#### Intervention 1

**Arm Group Labels:**

- User experience evaluation

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

**Name:** Interactive Artificial Intelligence

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Distress Thermometer

**Measure:** Distress

**Time Frame:** baseline

**Description:** WHOQOL

**Measure:** Quality of life measurement

**Time Frame:** baseline

**Description:** PSS-10 (Perceived Stress Scale)

**Measure:** Stress

**Time Frame:** baseline

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

**Measure:** Self-esteem

**Time Frame:** baseline

**Description:** Acceptance of Disability Scale

**Measure:** Acceptance of Disability

**Time Frame:** baseline

**Description:** PBPI (Pain belief \& Perception inventory)

**Measure:** Pain measurement

**Time Frame:** baseline

**Description:** ISI (Insomnia Severity Index)

**Measure:** Insomnia

**Time Frame:** baseline

**Description:** PSQI (Pittsburgh Sleep Quality Index)

**Measure:** Quality of sleep

**Time Frame:** baseline

**Description:** FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy)

**Measure:** Fatigue

**Time Frame:** baseline

**Description:** HADS (Hospital anxiety and depression scale)

**Measure:** Anxiety & Depression

**Time Frame:** baseline

**Description:** MINI-Plus (Mini-international Neuropsychiatric interview)

**Measure:** Suicidality

**Time Frame:** baseline

**Description:** FOP-SF (Fear of Disease Progression Short Form)

**Measure:** Fear of Disease Progression

**Time Frame:** baseline

**Description:** MOS Social support Survey

**Measure:** Social Support

**Time Frame:** baseline

### Eligibility Module

**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

**Minimum Age:** 19 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult cancer patients without severe cognitive decline

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** total3562@naver.com

**Name:** Sunhyung Lee, M.D.

**Phone:** 82-2-2072-3767

**Role:** CONTACT

**Contact 2:**

**Name:** Bong-jin Hahm, M.D., Ph.D.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** total3562@naver.com

- **Name:** Sunhyung Lee, M.D.

- **Phone:** 82-2-2072-3767

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Status:** RECRUITING

**Zip:** 16801

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** Bong-jin Hahm, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
