NCT07167056 Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer
| NCT ID | NCT07167056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-11-17 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Zeina Nahleh, MD, FACP
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic Florida
Frequently Asked Questions
Who can join the NCT07167056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07167056 currently recruiting?
Yes, NCT07167056 is actively recruiting participants. Contact the research team at nahlehz@ccf.org for enrollment information.
Where is the NCT07167056 trial being conducted?
This trial is being conducted at Weston, United States.
Who is sponsoring the NCT07167056 clinical trial?
NCT07167056 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Zeina Nahleh, MD, FACP at Case Comprehensive Cancer Center, Cleveland Clinic Florida. The trial plans to enroll 60 participants.
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