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RECRUITING

NCT07167056

Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: Artificial Intelligence-Powered Support For Quality Of Life Improvement In Patients With Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-17

Completion Date

2027-01-15

Last Updated

2025-11-28

Healthy Volunteers

Conditions

Cancer

Interventions

BEHAVIORAL

Standard of Care Psychotherapy

Participants will receive six psychotherapy sessions over the course of approximately 3 months.

BEHAVIORAL

WYSA App

Participants will have access to the WYSA mental health support artificial intelligence app over the course of the 3 months that they are participating in psychotherapy sessions per standard of care. The app will contain features intended to manage symptoms of depression and anxiety in individuals with cancer. The app will include an AI-powered chatbot with Cognitive Behavioral Therapy (CBT) and mindfulness techniques, visual progress elements (a progress roadmap, a weekly progress report, etc.), and a customizable tool library. Participants are instructed to use the app whenever they feel like it, if they are in distress, or if the app prompts them to use it. App prompts (notifications) will occur once daily.

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.

Locations (1)

Cleveland Clinic Florida

Weston, Florida, United States