AI-powered support to improve quality of life for people with cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with biopsy-proven stage I–III cancer who are receiving chemotherapy, immunotherapy, or radiation and who report significant distress will be enrolled and randomized to two groups. One group will receive usual psychotherapy care plus access to the WYSA AI-powered app, while the other group will receive usual psychotherapy care without the app. Participants in both arms will complete surveys about quality of life, anxiety, and depression over the course of their psychotherapy visits. The app uses CBT, mindfulness techniques, and mood tracking to provide daily support on a smartphone and does not replace clinical care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants in active cancer treatment (receiving chemotherapy, immunotherapy and/or radiation therapy) AND reporting National Comprehensive Cancer Network (NCCN) Distress Thermometer scores ≥4. The NCCN Distress Thermometer is a validated, single-item screening tool routinely used in cancer care at Cleveland Clinic Florida to identify individuals experiencing psychological distress. A score of 4 or higher indicates clinically significant distress and serves as the eligibility threshold for enrollment in this study.
* Participants followed by a medical oncologist, radiation oncologist, and/or surgical oncologist of any subspecialty at Cleveland Clinic Florida and have no barrier to receive psychotherapy care (e.g. no insurance restrictions)
* Participants with biopsy proven cancer of any type, stages I-III.
* Adults aged 18 years or older.
* Able to understand and read English and/or Spanish.
* Participants who own a smartphone compatible with the mobile app (Android or IOS) or have regular (Daily) access to one.
* Participants who are willing and able to provide informed consent.

Exclusion Criteria:

* Age \<18 years.
* Participants with stage 4 cancer.
* Participants with active severe psychiatric conditions identified by the Cleveland Clinic psychotherapist as any diagnoses that could significantly impair a participant's ability to engage meaningfully with the intervention or provide informed consent. These include, but are not limited to:

  * Current or recent (within the past 6 months) psychotic disorders (e.g., schizophrenia, schizoaffective disorder)
  * Bipolar disorder in a manic or severe depressive phase
  * Active suicidal ideation with intent or recent suicide attempt (within the past 6 months)
  * Severe cognitive impairment or neurocognitive disorders that compromise comprehension or communication or interferes with chatbot use.
  * Any condition requiring psychiatric hospitalization within the past 6 months
* Concurrent enrollment in another trial targeting psychological distress to avoid bias.
* Limited life expectancy (\<3 months) as determined by the oncologist.

Where it's running

• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting

Study contacts

• Principal investigator: Zeina Nahleh, MD, FACP — Case Comprehensive Cancer Center, Cleveland Clinic Florida
• Study coordinator: Zeina Nahleh, MD, FACP
• Email: nahlehz@ccf.org
• Phone: 954-659-5840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.