CancerONCO-AINCT06854315
Effect of ChatGPT-Based Digital Counseling on Anxiety and Depression in Cancer: A Randomized Trial
A study testing ChatGPT-Based Digital Counseling and Standard Clinician-Led Education in people with Cancer and Anxiety, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer, Anxiety, Depression
- What is being tested?
- ChatGPT-Based Digital Counseling and Standard Clinician-Led Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital
Ankara, Yenimahalle, 06170
Gazi University Faculty of Medicine, Department of Medical Oncology
Ankara, Yenimahalle, 06500
About this study
Official title: Effect of a ChatGPT-Based Digital Counseling Intervention on Anxiety and Depression in Patients With Cancer: A Prospective, Randomized Trial
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.
Read more
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.
Read the 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
- Being tested
- ChatGPT-Based Digital Counseling, Standard Clinician-Led Education
- Keywords
- Artificial Intelligence, Cancer Patient Education, Supportive Care, AI-Based Counseling
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPT-Based Digital CounselingBehavioural
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.
Standard Clinician-Led EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Clinician-Led Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The number and type of questions asked by participants in the ChatGPT-assisted group will be analyzed to assess differences in information-seeking behavior compared to the standard education group.
Measured: 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
The oncology specialists will review all AI-generated responses and classify them as "appropriate," "inappropriate," or "unreliable." The percentage of correct responses will be recorded.
Measured: Baseline and Day 21 (prior to Cycle 2, each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start2 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhun Akdoğan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854315
- Sponsor's protocol ID
- E-1096068
- Other IDs
- E-1096068
- Acronym
- ONCO-AI
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and institutional policies. The dataset contains sensitive patient information, and sharing is not planned to ensure patient confidentiality and compliance with ethical guidelines.
Publications
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.
PubMed 40215593
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a ChatGPT-Based Digital Counseling Intervention on Anxiety and Depression in Patients With Cancer: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT06854315
- Acronym / sponsor ID
- ONCO-AI / E-1096068
- Conditions
- Cancer, Anxiety, Depression, Artifical Intelligence
- Keywords
- Artificial Intelligence, Cancer Patient Education, Supportive Care, AI-Based Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ChatGPT-Arm | Experimental | Behavioral: ChatGPT-Based Digital CounselingParticipants 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. |
| Control Group | Other | Behavioral: Standard Clinician-Led EducationStandard pre-chemotherapy education was provided by oncologists and oncology nurses, covering expected side effects, treatment protocols, and general supportive care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatGPT-Based Digital CounselingParticipants 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. | Behavioural | ChatGPT-Arm |
| Standard Clinician-Led EducationParticipants 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. | Behavioural | Control Group |
Primary outcome
Change in Anxiety and Depression Scores (HADS-A and HADS-D)
Time frame: 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).
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.
2 secondary outcomes
Differences in Patient Engagement and Information-Seeking Behavior
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).
Accuracy and Reliability of ChatGPT Responses
Time frame: Baseline and Day 21 (prior to Cycle 2, each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Results publication: PubMed 40215593Akdogan 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and institutional policies. The dataset contains sensitive patient information, and sharing is not planned to ensure patient confidentiality and compliance with ethical guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChatGPT-Based Digital Counseling and Standard Clinician-Led Education in people with Cancer and Anxiety, run by Gazi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety and Depression Scores (HADS-A and HADS-D) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.