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

Part of paid clinical trials in Weston, Florida.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07167056
Status
Recruiting
Apply to this trial

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Psychotherapy — BEHAVIORAL
    Participants will receive six psychotherapy sessions over the course of approximately 3 months.
  • WYSA App — 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.

Study Details

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.

Key Dates

Start date
Nov 17, 2025
Status verified
May 2026
Primary completion
Nov 15, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Psychotherapy + WYSA App
  • Active Comparator: Standard of Care Psychotherapy

Primary Outcome Measure

Change in Quality of Life [ Time Frame: Baseline, 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FloridaWestonFlorida33331
Zeina Nahleh, MD, FACP
[email protected]
954-659-5840
Zeina Nahleh, MD, FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Weston, FL

By research site
Cleveland Clinic Florida· Weston, FL

Related Studies