To develop the E-MOTE robot and evaluate its effectiveness in addressing psychological distress, physical symptom, stress index, and quality of life, as well as to explore its clinical applicability.
This study is grounded in the Social Cognitive Theory of Self-Regulation as its theoretical framework and aims to develop a robot equipped with functions of Emotion, Monitor, Optimize, Tailor, and Engage (E-MOTE). The intervention is designed to support newly diagnosed gynecological cancer patients in more effectively managing their emotions throughout the surgical treatment process, with the goal of positively influencing symptom management and quality of life.At the same time, the investigators will conduct qualitative interviews with nursing staff to understand their perceptions and thoughts about the robot.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
130
Participants in the experimental group will receive the E-MOTE robot intervention on the first and second days after surgery. The intervention includes an emotional assessment, followed by appropriate dialogue modules tailored to the level of emotional distress. These are supplemented with emotion-generated empathetic conversations for deeper engagement, a session of self-affirmation relaxation training, and a subsequent Q\&A session.
National Taiwan University
Taipei, Taiwan
RECRUITINGDistress
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.
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.
Usability of the robot
Investigators used Bot Usability Scale(BUS) to asses the usability of the robot. The scale consists of 15 items, each rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), higher score indicates greater usability.
Time frame: Measurements will be taken three days post-surgery.
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.
Loneliness
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Investigators utilized the Caring Loneliness Scale to assess loneliness. The scale consists of 24 items, each rated on a 5-point Likert scale (1 = never, 5 = always), with higher scores indicating greater feelings of loneliness.
Time frame: 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.
Time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Physiological objective indicators
Objective physiological indicators were measured using wearable smart wristbands, including heart rate, heart rate variability, and stress index.
Time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.