Status:
RECRUITING
Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 inte...
Detailed Description
Getting a cancer diagnoses and going through treatment can be difficult and lead to symptoms of distress, like anxiety and depression. Feeling distressed or upset can make people with cancer feel wors...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07167056
Start Date
November 17 2025
End Date
January 15 2027
Last Update
November 28 2025
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331