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

Case Comprehensive Cancer Center (Case CCC)

Status

Enrolling

Conditions

Cancer

Treatments

Behavioral: Standard of Care Psychotherapy

Behavioral: WYSA App

Study type

Interventional

Funder types

Other

Identifiers

NCT07167056

CASE10Z25

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.