Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07167056

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

Led by Case Comprehensive Cancer Center · Updated on 2025-11-28

60

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

Sponsors

C

Case Comprehensive Cancer Center

Lead Sponsor

F

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

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be adults aged 18 years or older
  • Must be in active cancer treatment receiving chemotherapy, immunotherapy, and/or radiation therapy
  • Must have biopsy proven cancer of any type, stages I-III
  • Must have a distress score of 4 or higher on the National Comprehensive Cancer Network Distress Thermometer
  • Must be followed by a medical, radiation, or surgical oncologist at Cleveland Clinic Florida
  • Must have no barriers to receiving psychotherapy care (such as insurance restrictions)
  • Must be able to understand and read English and/or Spanish
  • Must own or have daily access to a smartphone compatible with the study app (Android or iOS)
  • Must be willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Diagnosis of stage 4 cancer
  • Active severe psychiatric conditions impairing participation or informed consent, including psychotic disorders, bipolar disorder in severe phase, active suicidal ideation with intent, recent suicide attempt, severe cognitive impairment, or recent psychiatric hospitalization
  • Enrollment in another trial targeting psychological distress
  • Limited life expectancy of less than 3 months as determined by the oncologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Florida

Weston, Florida, United States, 33331

Actively Recruiting

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Research Team

Z

Zeina Nahleh, MD, FACP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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