Advanced Cancer
Conditions
Keywords
Advanced Cancer, AI
Brief summary
Psychological issues in patients with advanced cancer are frequently overlooked, resulting in delayed or insufficient treatment. Current interventions are often limited by constraints related to space, location, and manpower, underscoring the need for accessible and feasible alternatives. This study examines the use of an AI emotional companion assistant and hypothesizes that, compared with the control group, the intervention group will experience improvements in depression, anxiety, and demoralization, along with enhanced quality of life and sleep quality. The study also aims to explore patients' experiences of interacting with the system.
Interventions
DEVICEAI Emotional Companion Assistants
The mobile application engages participants through a virtual character that conducts interactive conversations. The system integrates Azure OpenAI, speech synthesis, and emotion recognition technologies, enabling the virtual character to understand users' emotional states and provide empathetic support. When emotional instability is detected, the system proactively asks whether the user would like to speak with a real person and offers referral to a 24-hour human support hotline. After each conversation, the system conducts emotion analysis based on voiceprints and dialogue content, categorizing emotions into four types: happiness, fear, anger, and sadness. It also generates an emotional reflection summary and provides relevant action-oriented guidance. Additionally, the system features a "Guided Visualization World" that offers relaxing music and positive affirmations to enhance emotional well-being.
Sponsors
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* (1) Patients diagnosed with advanced cancer; (2) A score of 6 or higher on the Brief Symptom Rating Scale (BSRS-5); (3) Aged between 20 -65 years old; (4) Ability to communicate in Chinese; (5) Ownership of a smartphone with internet access and the ability to use it; (6) Willingness to participate in the study.
Exclusion criteria
* (1) Individuals determined by a physician to have suicidal ideation or tendencies; (2) A score of 2 or higher on the last item (suicidal thoughts) of the BSRS-5 scale; (3) Unable to communicate verbally.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Severity | From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention. | Change in Depression Severity: Depression severity will be assessed using a standardized depression scale. Scores will be analyzed as continuous variables. Unit of Measure: Scale score (e.g., 0-27) Interpretation: \<5 = normal 5-9 = mild 10-14 = moderate 15-19 = moderately severe ≥20 = severe |
| Change in Anxiety Severity | From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention. | Anxiety Severity will be assessed using a standardized anxiety scale. Scores will be analyzed as continuous variables. Unit of Measure: Scale score (e.g., 0-21) Interpretation: \<5 = normal 5-9 = mild 10-14 = moderate ≥15 = severe |
| Change in Demoralization Severity | From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention. | Demoralization severity will be assessed using a standardized demoralization scale. Scores will be analyzed as continuous variables. Unit of Measure: Scale score (e.g., 0-96) Interpretation: ≥30 = high |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention. | Quality of life will be assessed using a standardized quality of life scale. Scores will be analyzed as continuous variables. Unit of Measure: Scale score (e.g., 0-108) Interpretation: Higher scores indicate better quality of life. |
| Change in Sleep Quality | From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention. | Sleep quality will be assessed using a standardized sleep scale. Scores will be analyzed as continuous variables. Scale score (e.g., 0-21) Interpretation: 0-3 = normal 4-5 = suspected insomnia ≥6 = probable insomnia |
Countries
Taiwan
Outcome results
None listed