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

Effects of a Self-Regulation-Based E-MOTE Emotional Care Program Delivered Via an AI-Assisted Robot and Supported by Mobile Platforms for Newly Diagnosed Gynecologic Cancer Patients From Surgery to 6-Month Post-Discharge

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecological Cancers; Nursing; Psycho-Oncology
• Intervention / Treatment: Other: E-MOTE group

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun-Hsiang Lee Associate Professor, PhD; Phone Number: +886 978082338; Email: yhlee338@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

***Patients***

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unable to communicate clearly.
• Unwilling or unable to participate in the study in its entirety.

***Nurse***

Inclusion Criteria:

• Aged 18 years or older.
• As a clinical nurse and has cared for patients who received the E-MOTE robot

Exclusion Criteria:

- Unwilling to participate in the qualitative interview.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Routine care
Experimental: Intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Measurement	Investigator use the partial itmes of European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) to measure quality of life. These two item is scored on a scale from 1 to 7, with higher scores indicating better quality of life.	Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Symptom Severity	Investigators utilized the Numerical Rating Scale to assess participants' subjective experiences by measuring the severity of various symptoms over the past week. Each symptom was rated on a scale from 0 to 10 (0 = no symptoms at all, 10 = the worst severity the participant can imagine). Higher score indicate more severity. This items included difficulty urinating, lower limb lymphedema, hot flashes caused by premature menopause, and perineal dryness.	Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Stress Index	Objective physiological indicators were measured using wearable smart wristbands, and heart rate variability (HRV) was converted into a stress index using a predefined formula.	Measurements will be taken before the intervention, three days after surgery, and one week after discharge

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Robot; Psychological support; Artifical inteligence; Emotional assessment
• Other Study ID Numbers: 202602068RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No