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AI-Powered Support for Cancer Patients' Quality of Life

This study is for people with cancer who are currently receiving treatment (chemotherapy, immunotherapy, and/or radiation therapy) and are experiencing distress. The research aims to see if an artificial intelligence (AI) app called WYSA, used alongside standard psychotherapy (talk therapy), can improve your quality of life, anxiety, and depression symptoms. You would be randomly assigned to one of two groups: one group will receive psychotherapy and access to the WYSA app, while the other group will only receive psychotherapy. The study will measure changes in your quality of life at the beginning and after three months. This study is currently recruiting 60 participants aged 18 and older.

Study design
This is an interventional study with 60 planned participants. You would be randomly assigned to one of two groups.
What's involved
Participants will receive six psychotherapy sessions over approximately 3 months. One group will also have access to the WYSA app for 3 months.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured at the beginning of the study and again after 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07167056

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

Recruiting
NAAges 18+InterventionalSupportive care
Case Comprehensive Cancer Center
~60 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Standard of Care PsychotherapyWYSA App

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Quality of Life
Measured over Baseline, 3 months

Conditions

Cancer

Explore related trials

Malignant Neoplasm

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Zeina Nahleh, MD, FACP · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic Florida

Who to contact

Zeina Nahleh, MD, FACP
[email protected]
954-659-5840
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Quality of LifeBaseline, 3 months

    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.