RecruitingNANCT07167056

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

Sponsor: Case Comprehensive Cancer Center

Trial Details

ConditionCancer
InterventionStandard of Care Psychotherapy; WYSA App
PhaseNA
StatusRecruiting
Participants60
Est. Completion15 Nov 2026
Last Updated15 May 2026

Primary Outcome

Change in Quality of Life

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

United States
View Registry Entry

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