Clinical trial NCT06854315: Effect of ChatGPT-Based Digital Counseling on Anxiety and Depression in Cancer: A Randomized Trial
Official title: Effect of a ChatGPT-Based Digital Counseling Intervention on Anxiety and Depression in Patients With Cancer: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Anxiety
Depression
Artifical Intelligence
Keywords: Artificial Intelligence
Cancer Patient Education
Supportive Care
AI-Based Counseling
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study used a parallel assignment model in which participants were randomly assigned to one of two groups: (1) the ChatGPT-assisted counseling group, which received standard chemotherapy education plus access to ChatGPT for personalized inquiries, or (2) the control group, which received standard clinician-led chemotherapy education alone. Both groups were followed simultaneously to assess changes in anxiety and depression levels before the second chemotherapy cycle.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

Age ≥18 years Newly diagnosed solid tumor (treatment-naïve) Scheduled to begin first-line chemotherapy ECOG performance status ≤2 Sufficient cognitive function to understand and complete the Hospital Anxiety and Depression Scale (HADS) questionnaire Ability to provide written informed consent

Exclusion Criteria:

Recurrent or metastatic cancer requiring urgent treatment Cognitive impairment that affects the ability to understand or complete the Hospital Anxiety and Depression Scale (HADS) questionnaire Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe major depressive disorder) that could interfere with study participation Concurrent participation in another interventional study related to psychological support or digital counseling

Primary outcomes:
measure: Change in Anxiety and Depression Scores (HADS-A and HADS-D)
timeFrame: Time Frame: Change in Hospital Anxiety and Depression Scale (HADS-A, HADS-D) scores from baseline to prior to the second chemotherapy cycle (each cycle is 21 days).
Secondary outcomes:
measure: Differences in Patient Engagement and Information-Seeking Behavior
timeFrame: Change in Hospital Anxiety and Depression Scale (HADS-A, HADS-D) scores from baseline to prior to the second chemotherapy cycle (each cycle is 21 days).
measure: Accuracy and Reliability of ChatGPT Responses
timeFrame: Baseline and Day 21 (prior to Cycle 2, each cycle is 21 days)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
state: Yenimahalle
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine, Department of Medical Oncology
state: Yenimahalle
Study officials:
References:
citation: Akdogan O, Uyar GC, Yesilbas E, Baskurt K, Malkoc NA, Ozdemir N, Yazici O, Oksuzoglu B, Uner A, Ozet A, Sutcuoglu O. Effect of a ChatGPT-based digital counseling intervention on anxiety and depression in patients with cancer: A prospective, randomized trial. Eur J Cancer. 2025 May 15;221:115408. doi: 10.1016/j.ejca.2025.115408. Epub 2025 Apr 3.