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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Unable to communicate clearly.

Unwilling or unable to participate in the study in its entirety.

Aged 18 years or older.

As a clinical nurse and has cared for patients who received the E-MOTE robot

Trial design

Design model

Parallel

Treatments tested in this trial

  • E-MOTE group

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
2

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.

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

Secondary outcomes

1

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.

Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge
2

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.

Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge
3

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.

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

Other outcomes

Sponsors and contacts

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