Effects of a Self-Regulation Based E-MOTE Program Delivered Via an AI-Assisted Robot and Supported by Mobile Platforms for Newly Diagnosed Gynecologic Cancer Patients

NCT07745478 | Not Yet Recruiting

• 1 other identifier: 202602068RINC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of the E-MOTE Emotional Care Program, delivered through the Kebbi robot and the LINE Official Account, for patients newly diagnosed with gynecologic cancer undergoing surgery. The primary outcomes are psychological distress , and the secondary outcomes are physical symptoms, stress index, and quality of life.

Conditions

Nursing; Gynecological Cancers; Psycho-Oncology

Keywords

Artifical inteligence; Robot; Emotional assessment; Psychological support

Outcome Measures

Primary Outcomes (2)

• Distress

  Investigators utilized the Distress Thermometer(DT) as the primary outcome measure. The scale uses a 11 Liker scale, where 0 indicates no distress at all and 10 represents the most severe distress.Higher score indicates a more severe distress. When the score is 4 or higher, a Problem List (PL) is used to further identify factors contributing to the emotional distress.

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

• Depression

  Investigators utilized the Patient Health Questionnaire (PHQ-9) as the primary outcome measure to assess depression. The scale consists of 9 items, each rated on a 4-point Likert scale (0 = not at all, 3 = nearly every day). The total score ranges from 0 to 27, and depression severity can be categorized as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20 or above).Higher score indicates a more severe depression.

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge

Secondary Outcomes (3)

• Quality of Life Measurement

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge

• Symptom Severity

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge

• Stress Index

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge

Study Arms (2)

Control Group

NO INTERVENTION

Routine care

Intervention Group

EXPERIMENTAL

The intervention group will receive the E-MOTE program, which includes emotional assessments, a self-relaxation training session, and a Q\&A session delivered via the Kebbi AI robot during hospitalization. After discharge, participants will continue to receive the program through the LINE Official Account.

Other: E-MOTE group

Interventions

E-MOTE group OTHER

Participants in the experimental group will receive the E-MOTE program during hospitalization on the day before surgery, postoperative day 1, and postoperative day 2 via the AI robot. The intervention includes an emotional assessment, followed by dialogue modules tailored to the participant's level of emotional distress, emotion-generated empathetic conversations, a self-affirmation relaxation training session, and a Q\&A session. After discharge, participants will continue to receive the E-MOTE program through the LINE Official Account.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Diagnosed with gynecologic cancer and undergoing surgery.
• Willing to receive E-MOTE robot and wear a smart wearable device.
• Willing to complete pre-test and post-test questionnaires.

You may not qualify if:

• Unable to communicate clearly.
• Unwilling or unable to participate in the study in its entirety.
• \*\*\*Nurse\*\*\*
• Aged 18 years or older.
• As a clinical nurse and has cared for patients who received the E-MOTE robot
• \- Unwilling to participate in the qualitative interview.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

Central Study Contacts

Yun-Hsiang Lee Associate Professor, PhD

CONTACT

+886 978082338; yhlee338@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This intervention module will first classify different levels of emotional distress using the PHQ-8, then provide corresponding and tailored dialogue modules . These will be accompanied by emotion-generated empathetic conversations for deeper engagement, followed by a guided session of self-affirmation relaxation training. Subsequently, a Q\&A session on the self-affirmation relaxation training will be conducted to reinforce the practice.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

TW (1)