Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07745478

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Nursing Gynecological Cancers Psycho-Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

***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.

Treatment and study plan

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.

Primary outcomes

  1. Distress

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

    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.

  2. Depression

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

    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.

Secondary outcomes

  1. Quality of Life Measurement

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

    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.

  2. Symptom Severity

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

    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.

  3. Stress Index

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

    Objective physiological indicators were measured using wearable smart wristbands, and heart rate variability (HRV) was converted into a stress index using a predefined formula.

Study contacts

Contact information is provided by the study sponsor or research team.

Yun-Hsiang Lee Associate Professor, PhD

CONTACT

[email protected]

+886 978082338

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.