Not Yet RecruitingNot Applicable

Psychosocial Effects of a Trauma-Informed Artificial Intelligence-Supported Chatbot in Adults Newly Diagnosed With Cancer

62 participantsStarted 2026-07-01

Plain-language summary

The goal of this clinical trial is to evaluate whether a trauma-informed, artificial intelligence-supported chatbot can reduce psychological distress and unmet psychosocial needs in adults newly diagnosed with cancer.: * Does the chatbot reduce trauma-related distress and anxiety levels compared to standard care? * Does the chatbot decrease unmet psychosocial needs in patients following a new cancer diagnosis? Researchers will compare the chatbot intervention to standard care to determine whether the chatbot provides additional psychosocial benefit. Participants will: * Be randomly assigned to either the chatbot intervention group or the standard care group * Use the chatbot freely for 12 weeks (intervention group only) * Complete questionnaires at baseline, 1 month, and 3 months * Be monitored for any psychological risk indicators during the study period

Who can participate

Age range

18 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: * Over 18 years of age, * Able to speak and understand Turkish, * Without any cognitive, visual, or auditory impairments, * Diagnosed with cancer within the last month (Stage I, II, and III) (regardless of cancer type), * Have started active cancer treatment, * Have access to a digital device and the internet, * Volunteer to participate in the study will be included. Exclusion Criteria: * Patients participating in another simultaneous psychosocial/digital intervention study, * Patients diagnosed with advanced stage (Stage IV) cancer, in the terminal phase and with metastases, * Patients diagnosed with schizophrenia, bipolar disorder, substance abuse, depression and anxiety disorders will be excluded.

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

Trauma-related distress

Timeframe: Baseline, 1 and 3 months

Trial details

NCT IDNCT07583069

SponsorKoç University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Nevra Didem Kılınç, PhD(c)

+9 0539 436 53 17 nozluk23@ku.edu.tr

View on ClinicalTrials.gov More Cancer trials