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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT04862195
Eligibility Criteria:
Inclusion Criteria:
* Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
* Are experiencing at least moderate anxiety (GAD-7 \>10) or mild-to-moderate depression (PHQ-8 score 5-11);
* Are fluent in English; and
* Have access to smartphone, or tablet capable of running iOS or Android software.
Exclusion Criteria:
* Previous history of cancer;
* \<2-yr survival prognosis as determined by treating clinician;
* Currently participating in investigative CBT trial for treatment of anxiety or depression;
* Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study;
* Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics-sponsored study; and
* PHQ-9 Q9 response \>0 AND Columbia Suicide Severity Risk Scale (or equivalent) score of Category 2- "suicidal ideation" at screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04862195
Study Brief:
Protocol Section:
NCT04862195