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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Cancer Anxiety Depression Artifical Intelligence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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ChatGPT-Arm

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.

Group Type EXPERIMENTAL

ChatGPT-Based Digital Counseling

Intervention Type 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.

Control Group

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

Group Type OTHER

Standard Clinician-Led Education

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No