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Not yet recruiting NCT07505732

Information-providing Chatbot

No phase Interventional Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ASCC (sarcoma-specific AI chatbot), Routine Clinical Care.
Who it may be relevant to
Registry conditions: Sarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Development and Evaluation of a Co-designed, AI-based Information-providing Chatbot for Sarcoma Patients: A Pilot Randomised Controlled Trial

Overview

This study aims to develop and examine the feasibility and preliminary effectiveness of an AI-based sarcoma chatbot building on ChatGPT (ASCC) to address the information needs of sarcoma patients. We hypothesized: 1) the ASCC will demonstrate good usability; 2) the study will be feasible in terms of all feasibility indicators; 3) the experimental group will report improved satisfaction and self-efficacy, decreased anxiety and stress than the control groups upon completion of the intervention. The ASCC will be developed using a co-design approach. A pilot randomized controlled trial will then be conducted in the three oncology wards of collaborative hospitals. Seventy-eight sarcoma patients will be recruited and randomized to the experimental group (n=39) and the control group (n=39). The experimental group will use the ASCC available 24/7 via voice or text for disease-related questions for one month while the control group will receive usual care.

Interventions

  • Other ASCC (sarcoma-specific AI chatbot)
    The participants in the experimental group will access the ASCC via a webpage alongside standard information from health professionals for one month (15 minutes weekly).
  • Other Routine Clinical Care
    Participants in the control group will receive routine clinical care, including standard information from doctor-patient consultations (e.g., diagnosis, treatment, medical tests) and hospital provided sarcoma and treatment leaflet.

Primary outcome measures

  • Screening rate [Time frame: During the enrollment period of this project.]
  • Eligibility rate [Time frame: During the enrollment period of this project.]
  • Consent rate [Time frame: During the enrollment period of this project.]
  • Randomization rate [Time frame: During the enrollment period of this project.]
  • Attendance rate [Time frame: Baseline and immediately after intervention (T1)]
  • Retention rate [Time frame: Baseline and immediately after intervention (T1)]
  • Completion rate [Time frame: Baseline and immediately after intervention (T1)]
  • Proportion of missing data [Time frame: Baseline and immediately after intervention (T1)]
  • Adverse events [Time frame: immediately after intervention (T1)]
Secondary outcome measures (4)
  • Information satisfaction [Time frame: Baseline and immediately after intervention (T1)]
  • Anxiety and stress [Time frame: Baseline and immediately after intervention (T1)]
  • Self-efficacy [Time frame: Baseline and immediately after intervention (T1)]
  • System Usability Scale [Time frame: immediately after intervention (T1)]

Eligibility criteria

Inclusion criteria

  • (1) diagnosed with soft tissue sarcoma;
  • (2) receiving active treatment at any stage;
  • (3) aged≥18 years;
  • (4) able to speak Cantonese, Mandarin and English;
  • (5) access to an electronic device enabling ASCC use

Exclusion criteria

  • (1) patients with unstable physical or mental conditions;
  • (2) inability to communicate logically;
  • (3) using chatbots (e.g., ChatGPT, Deepseek) for sarcoma information in the last month;
  • (4) mental health disorders documented by the medical system

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07505732 · ASCC Intervention

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗