Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT07167056
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07167056
Study Brief:
Protocol Section:
NCT07167056