Clinical trial · Interventional
Effect of ChatGPT-Based Digital Counseling on Anxiety and Depression in Cancer: A Randomized Trial
Effect of a ChatGPT-Based Digital Counseling Intervention on Anxiety and Depression in Patients With Cancer: A Prospective, Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Artifical Intelligence | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ChatGPT-Based Digital Counseling | Behavioral | — | UNRESOLVED |
| Standard Clinician-Led Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ChatGPT-Arm
- description
- 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.
- interventionNames
- Behavioral: ChatGPT-Based Digital Counseling
- type
- OTHER
- label
- Control Group
- description
- Standard pre-chemotherapy education was provided by oncologists and oncology nurses, covering expected side effects, treatment protocols, and general supportive care.
- interventionNames
- Behavioral: Standard Clinician-Led Education
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAkdogan 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