AI-powered support to improve quality of life for people with cancer
Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients With Cancer
This study will try an AI-powered smartphone app together with regular talk therapy to see if it improves quality of life, anxiety, and depression in adults with stage I–III cancer who are receiving active treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Weston, Florida) |
| Trial ID | NCT07167056 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) with biopsy-proven stage I–III cancer who are receiving active cancer treatment, have an NCCN Distress Thermometer score of ≥4, are followed at Cleveland Clinic Florida, and own a compatible smartphone and read English or Spanish.
Not a fit: Patients unlikely to benefit include those without clinically significant distress (Distress Thermometer <4), those not in active treatment or with stage IV disease, those without a compatible smartphone, or those whose mental health needs require immediate or specialist psychiatric care beyond a digital app.
Why it matters
Potential benefit: If successful, adding an AI app to psychotherapy could lower anxiety and depression and improve day-to-day quality of life while expanding access to supportive tools between clinical visits.
How similar studies have performed: Digital CBT and AI chatbot tools have reduced anxiety and depression in general populations, but their effectiveness specifically for people undergoing cancer treatment is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Weston, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.