Advanced CancerAI CancerNCT07793084
The Effectiveness of the Psychological Care of AI Emotional Companion Assistants Among Patients With Advanced Cancer
A study testing AI Emotional Companion Assistants in people with Advanced Cancer, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AI Emotional Companion Assistants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Advanced Cancer
- Being tested
- AI Emotional Companion Assistants
- Keywords
- Advanced Cancer, AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Emotional Companion AssistantsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | AI Emotional Companion group Receives: Device: AI Emotional Companion Assistants |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Severity
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
Measured: 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 Anxiety Severity
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
Measured: 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 Demoralization Severity
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
Measured: From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention.
Secondary outcomes (2)
Change in Quality of Life
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.
Measured: 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 Sleep Quality
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
Measured: From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start4 Nov 2024
- Primary completion22 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793084
- Sponsor's protocol ID
- 2024-08-001C
- Acronym
- AI Cancer
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Psychological Care of AI Emotional Companion Assistants Among Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT07793084
- Acronym / sponsor ID
- AI Cancer / 2024-08-001C
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, AI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: AI Emotional Companion AssistantsAI Emotional Companion group |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
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 |
|---|---|---|
| AI Emotional Companion AssistantsThe 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. | Device | Experimental |
Primary outcome
Change in Depression Severity
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Change in Quality of Life
Time frame: 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 Sleep Quality
Time frame: From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Emotional Companion Assistants in people with Advanced Cancer, run by National Yang Ming Chiao Tung University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Severity (time frame: From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention.). The study lists 3 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 28 Aug 2026.