NursingNCT07745478
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
A study testing E-MOTE group in people with Nursing and Gynecological Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing, Gynecological Cancers, Psycho-Oncology
- What is being tested?
- E-MOTE group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Aged 18 years or older.
- As a clinical nurse and has cared for patients who received the E-MOTE robot
Who cannot join
- Unable to communicate clearly.
- Unwilling or unable to participate in the study in its entirety.
- Nurse
- Unwilling to participate in the qualitative interview.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- E-MOTE group
- Keywords
- Artifical inteligence, Robot, Emotional assessment, Psychological support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-MOTE groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: E-MOTE group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745478
- Sponsor's protocol ID
- 202602068RINC
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07745478
- Acronym / sponsor ID
- 202602068RINC
- Conditions
- Nursing, Gynecological Cancers, Psycho-Oncology
- Keywords
- Artifical inteligence, Robot, Emotional assessment, Psychological support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine care |
| Intervention Group | Experimental | Other: E-MOTE groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Aged 18 years or older.
Key exclusion criteria (4 listed)
- Unable to communicate clearly.
- Unwilling or unable to participate in the study in its entirety.
- Nurse
- Unwilling to participate in the qualitative interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-MOTE groupParticipants 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. | Other | Intervention Group |
Primary outcome
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.
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.
3 secondary outcomes
Quality of Life Measurement
Time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Symptom Severity
Time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Stress Index
Time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-MOTE group in people with Nursing and Gynecological Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun-Hsiang Lee Associate Professor, PhD (+886 978082338, yhlee338@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress (time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.