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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07745478
Enrollment
120
Registered
2026-08-04
Start date
2026-09-01
Completion date
2028-07-31
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Cancers, Nursing, Psycho-Oncology

Keywords

Artifical inteligence, Robot, Emotional assessment, Psychological support

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.

Interventions

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\*\*\*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

Design outcomes

Primary

MeasureTime frameDescription
DistressMeasurements 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.
DepressionMeasurements will be taken before the intervention, three days after surgery, and one week after dischargeInvestigators 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

MeasureTime frameDescription
Quality of Life MeasurementMeasurements will be taken before the intervention, three days after surgery, and one week after dischargeInvestigator 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.
Symptom SeverityMeasurements will be taken before the intervention, three days after surgery, and one week after dischargeInvestigators 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.
Stress IndexMeasurements will be taken before the intervention, three days after surgery, and one week after dischargeObjective physiological indicators were measured using wearable smart wristbands, and heart rate variability (HRV) was converted into a stress index using a predefined formula.

Countries

Taiwan

Contacts

CONTACTYun-Hsiang Lee Associate Professor, PhD
yhlee338@ntu.edu.tw+886 978082338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026