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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).