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

NCT07167056 | Recruiting DMC

• 1 other identifier: CASE10Z25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Psychotherapy; Mental health; Distress; Stage I Cancer; Stage II Cancer; Stage III Cancer; Chatbot; Artificial Intelligence; AI

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months

Secondary Outcomes (35)

• Change in Anxiety

  Baseline, 3 months

• Change in Depression

  Baseline, 3 months

• Change in physical functioning

  Baseline, 3 months

• Change in role functioning

  Baseline, 3 months

• Change in emotional functioning

  Baseline, 3 months

Study Arms (2)

Psychotherapy + WYSA App

EXPERIMENTAL

Behavioral: Standard of Care Psychotherapy; Behavioral: WYSA App

Standard of Care Psychotherapy

ACTIVE COMPARATOR

Behavioral: Standard of Care Psychotherapy

Interventions

Standard of Care Psychotherapy BEHAVIORAL

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

Psychotherapy + WYSA App; Standard of Care Psychotherapy

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.

Psychotherapy + WYSA App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Florida Department of Health (Casey DeSantis Florida Cancer Innovation Fund): collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Zeina Nahleh, MD, FACP

  Case Comprehensive Cancer Center, Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeina Nahleh, MD, FACP

CONTACT

954-659-5840; nahlehz@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)