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

NCT ID: NCT07167056

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2027-01-15

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 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.

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 worse and potentially shorten how long they live. Because of this, it is important to address the distress that people with cancer may feel in order to improve their well-being. Treatments that don't use medication, like psychotherapy ("talk therapy), relaxation techniques, and mindfulness, can help reduce distress in people with cancer. However, some people do not have access to these types of things, and mental health care overall can be limited by financial, logistical, and geographical barriers. One solution to these barriers could be artificial intelligence (AI)-powered interventions using mobile applications (apps) on someone's phone. AI tools, like chatbots, can provide personal support. They can use Cognitive Behavioral Therapy (CBT) and mindfulness to provide support. They can also provide tools to track someone's mood. AI tools do not replace a diagnosis from a doctor or treatment from a doctor or other clinical care provider. However, these tools could still support and help to improve someone's mental health and well-being. People who have studied this have found that this day-to-day support has decreased anxiety and depression in the general population. However, the use of AI tools to support mental health in people with cancer is not yet well studied.

WYSA is an AI-powered chatbot that uses evidence-based techniques like Cognitive Behavioral Therapy (CBT) and mindfulness. For the purposes of this study, WYSA will be used in addition to standard of care psychotherapy. WYSA will not replace psychotherapy care in this study, and it will not replace a doctor's advice or diagnoses.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psychotherapy + WYSA App

Group Type: EXPERIMENTAL

WYSA App

Intervention Type: BEHAVIORAL

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.

Standard of Care Psychotherapy

Intervention Type: BEHAVIORAL

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

Standard of Care Psychotherapy

Group Type: ACTIVE_COMPARATOR

Standard of Care Psychotherapy

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care Psychotherapy

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)

UNKNOWN

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeina Nahleh, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center, Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zeina Nahleh, MD, FACP

Role: CONTACT

nahlehz@ccf.org

954-659-5840

Facility Contacts

Zeina Nahleh, MD, FACP

Role: primary

nahlehz@ccf.org

954-659-5840

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Other Identifiers

CASE10Z25

Identifier Type: -

Identifier Source: org_study_id