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Completed

NCT Number: NCT07793084

The Effectiveness of the Psychological Care of AI Emotional Companion Assistants Among Patients With Advanced Cancer

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.

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Key information

Conditions

Advanced Cancer

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, 155, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI Emotional Companion Assistants

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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

Other outcomes

  1. Experiences of Interacting With the AI Emotional Companion

    Time frame: From enrollment to the end of intervention at 12 weeks. Post-test is at 12weeks after intervention.

    Semi-structured interviews will be conducted with participants in the intervention group to explore their experiences, perceptions, and interactions with the AI emotional companion assistant.

  2. System Usability

    Time frame: From enrollment to the end of intervention at 12 weeks. Post-test is at 12weeks after intervention.

    System usability 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: higher score = better usability

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Acronym: AI Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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