Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients With Cancer
Trial ID: NCT07167056
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-11-17
Completion date: 2027-01-15
Sponsor: Case Comprehensive Cancer Center
Collaborators: Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)
Conditions: Cancer
Interventions: Standard of Care Psychotherapy; WYSA App
Locations: Cleveland Clinic Florida
Countries: United States
Enrollment: 60
Age range: 18 Years - None
Sex: ALL

Summary:
This research study is for people who are diagnosed with cancer and are receiving treatment for cancer who may benefit from psychotherapy. The purpose of the study is to see whether an artificial intelligence (AI) powered application (app) could help improve quality of life, anxiety symptoms, and/or depression symptoms, over the course of psychotherapy sessions. Participants in this study will be randomly assigned to one of two groups. One group will receive psychotherapy per usual care and will receive access to the AI-powered app. The second group will only receive psychotherapy per usual care and will NOT receive access to the AI-powered app. Both groups will complete surveys about their quality of life, anxiety symptoms, and depression symptoms over the course of their psychotherapy visits.

Eligibility 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.

Outcomes:
Change in Quality of Life