IRB Study Number 25-705
Status Recruiting
Location Weston Medical Outpatient Center
Institute Taussig Cancer Institute
Description
Aim 1:
To compare the change in quality of life (QoL) from baseline using the EORTC QLQ-C30 score in the intervention (AIP) and control (SOC) groups.
Aim 2:
- To Evaluate the changes in anxiety (GAD-7) and depression (PHQ-9) scores in the 2 groups
- To report on user engagement with the AI application
- To Report any adverse events in either group
- To evaluate the change in QoL according to number of psychotherapy visits
- To assess the change in QoL according to patient characteristics
Inclusion Criteria
Patients in active cancer treatment (receiving chemotherapy, immunotherapy and/or radiation therapy) AND reporting NCCN Distress Thermometer scores ≥4 (Appendix 4). The NCCN Distress Thermometer is a validated, single-item screening tool routinely used in cancer care at Cleveland Clinic Florida to identify patients experiencing psychological distress. A score of 4 or higher indicates clinically significant distress and serves as the eligibility threshold for enrollment in this study. At this institution, it is standard practice to refer patients with an NCCN Distress Thermometer score of 4 or higher to psychotherapy, therefore, participants will include individuals with an NCCN distress score greater than 4 who are either newly referred to and attending therapy for the first time or those who are already engaged in ongoing therapy sessions.
Patients 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)
Patients 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.
Patients who own a smartphone compatible with the mobile app (Android or IOS) or have regular (Daily) access to one.
Patients who are willing and able to provide informed consent.
Exclusion Criteria
- Age <18 years.
- Patients with stage 4 cancer.
- Patients with active severe psychiatric conditions identified by our 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.
