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.
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.
Age <18 years.
Participants with stage 4 cancer.
Current or recent (within the past 6 months) psychotic disorders (e.g., schizophrenia, schizoaffective disorder)
Bipolar disorder in a manic or severe depressive phase
Parallel
Standard of Care Psychotherapy
BehavioralParticipants will receive six psychotherapy sessions over the course of approximately 3 months.
WYSA App
BehavioralParticipants 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.
Change in Quality of Life
Quality of life (QoL) is measured by the global health status/QoL subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. The global health status/QoL subscale contains two questions, where participants provide an answer on a 7-point Likert scale from "Very poor" (1) to "Excellent" (7). Higher scores indicate greater global health status/QoL.
Change in Anxiety
Anxiety is measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. The questionnaire contains 7 questions asking participants about their anxiety symptoms on a 4-point Likert scale from "Not at all" (0) to "Nearly every day" (3). There is one questions regarding how difficult these symptoms have made daily life, where participants provide an answer on a 4-point scale from "Not difficult at all" to "Extremely difficult." Higher scores indicate greater anxiety symptoms.
Change in Depression
Depression is measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 contains 8 questions asking participants about their depression symptoms on a 4-point Likert scale from "Not at all" (0) to "Nearly every day" (3). There is one questions regarding how difficult these symptoms have made daily life, where participants provide an answer on a 4-point scale from "Not difficult at all" to "Extremely difficult." Higher scores indicate greater depression symptoms.
Change in physical functioning
Physical functioning is measured by the physical functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains five questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower physical functioning.
Change in role functioning
Role functioning is measured by the role functioning (functional scale) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 questionnaire. It contains two questions, where participants provide an answer on a 4-point Likert scale from "Not at all" (1) to "Very Much" (4). Higher scores indicate lower role functioning.
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Case Comprehensive Cancer Center
Lead sponsor
Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)
Collaborator
