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

NCT06854315 | Completed

• 1 other identifier: E-1096068
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Anxiety; Depression; Artifical Intelligence

Keywords

Artificial Intelligence; Cancer Patient Education; Supportive Care; AI-Based Counseling

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety and Depression Scores (HADS-A and HADS-D)

  The primary outcome is the change in Hospital Anxiety and Depression Scale (HADS-A, HADS-D) scores between baseline and the second chemotherapy cycle. The difference between groups will be assessed to determine the impact of ChatGPT-assisted counseling on anxiety and depression levels in newly diagnosed cancer patients.

  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 (2)

• Differences in Patient Engagement and Information-Seeking Behavior

  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).

• Accuracy and Reliability of ChatGPT Responses

  Baseline and Day 21 (prior to Cycle 2, each cycle is 21 days)

Study Arms (2)

ChatGPT-Arm

EXPERIMENTAL

Participants in this group received standard clinician-led chemotherapy education plus access to ChatGPT-based digital counseling. They were allowed to submit up to 10 personalized questions to ChatGPT regarding their treatment. All AI-generated responses were reviewed for accuracy by oncology specialists.

Behavioral: ChatGPT-Based Digital Counseling

Control Group

OTHER

Standard pre-chemotherapy education was provided by oncologists and oncology nurses, covering expected side effects, treatment protocols, and general supportive care.

Behavioral: Standard Clinician-Led Education

Interventions

ChatGPT-Based Digital Counseling BEHAVIORAL

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.

ChatGPT-Arm

Standard Clinician-Led Education BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine, Department of Medical Oncology

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40215593 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study used an outcomes assessor-blinded design, meaning that the researchers responsible for analyzing the primary and secondary outcomes were blinded to group allocation. However, participants, care providers, and investigators were aware of the assigned intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Gazi University Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 3, 2025
• Study Start: July 2, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)