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

NCT07793084 | Completed DMC

• 1 other identifier: 2024-08-001C
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; AI

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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

  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

  From enrollment to the end of intervention at 12 weeks. Post-test is held at 6 weeks, 12 weeks and 24 weeks after intervention.

Other Outcomes (2)

• Experiences of Interacting With the AI Emotional Companion

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

• System Usability

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

Study Arms (2)

Experimental

EXPERIMENTAL

AI Emotional Companion group

Device: AI Emotional Companion Assistants

Control

NO INTERVENTION

Control

Interventions

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.

Experimental

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 155, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 28, 2026
• Study Start: November 4, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2026

Record last verified: 2024-11

Locations

TW (1)