NCT06854315

Effect of ChatGPT-Based Digital Counseling on Anxiety and Depression in Cancer: A Randomized Trial

Effect of a ChatGPT-Based Digital Counseling Intervention on Anxiety and Depression in Patients With Cancer: A Prospective, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the impact of a ChatGPT-based digital counseling intervention on anxiety and depression in newly diagnosed cancer patients undergoing chemotherapy. Patients are randomly assigned to one of two groups: ChatGPT Group: Patients receive standard chemotherapy education plus access to ChatGPT, where they can ask up to 10 personalized questions about their treatment. Control Group: Patients receive only standard chemotherapy education provided by oncologists and nurses. The primary outcome is the change in anxiety and depression levels, measured using the Hospital Anxiety and Depression Scale (HADS), recorded at baseline and before the second chemotherapy cycle. Secondary outcomes include patient engagement patterns, the types of questions asked, and an assessment of ChatGPT's responses by oncologists. This study seeks to explore whether AI-based digital counseling can serve as a complementary support tool for newly diagnosed cancer patients.

Detailed description

Study Design This prospective, randomized controlled trial aims to evaluate the effects of a ChatGPT-based digital counseling intervention on anxiety and depression in newly diagnosed cancer patients undergoing chemotherapy. The study is conducted at two oncology centers between July 2024 and December 2024. Patients are randomly assigned (1:1) to either: ChatGPT-Assisted Counseling Arm: Patients receive standard chemotherapy education plus the ability to ask up to 10 personalized questions to ChatGPT. All AI-generated responses are reviewed for accuracy by oncology specialists. Standard Education Arm: Patients receive only clinician-led chemotherapy education, without AI-based support. Primary and Secondary Outcomes Primary Outcome: Change in Hospital Anxiety and Depression Scale (HADS-A, HADS-D) scores between baseline and prior to the second chemotherapy cycle. Secondary Outcomes: Differences in patient engagement behaviors and information-seeking patterns. Analysis of the accuracy and reliability of ChatGPT-generated responses. The role of AI in addressing sensitive or under-discussed topics in oncology education (e.g., sexual health, alternative medicine). Statistical Analysis The sample size is estimated based on detecting a 2-point difference in HADS scores (α=0.05, power=80%). Nonparametric tests (Mann-Whitney U test, Wilcoxon signed-rank test) are planned for within- and between-group comparisons. Multivariable logistic regression will assess independent predictors of anxiety reduction.

Conditions

• Cancer
• Anxiety
• Depression
• Artifical Intelligence

Interventions

Type	Name	Description
BEHAVIORAL	ChatGPT-Based Digital Counseling	Participants in this group received standard clinician-led chemotherapy education plus access to ChatGPT-based digital counseling. They could submit up to 10 personalized questions regarding their treatment, side effects, and supportive care. Oncology specialists reviewed ChatGPT-generated responses for accuracy. This intervention aimed to assess whether AI-assisted counseling could reduce anxiety and depression levels in newly diagnosed cancer patients.
BEHAVIORAL	Standard Clinician-Led Education	Participants in this group received only standard clinician-led chemotherapy education, delivered by oncology physicians and nurses. The education covered key aspects of chemotherapy, including potential side effects, treatment schedules, and supportive care recommendations. Unlike the ChatGPT group, these participants did not receive AI-assisted counseling or additional interactive educational tools.

Timeline

• Start date: 2024-07-02
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2025-03-03
• Last updated: 2025-04-16

Locations

2 sites across 1 country: Turkey (Türkiye)