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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT07122492
Eligibility Criteria:
Inclusion Criteria:
* Participant must be ≥ 18 years of age.
* Participant must have had histologically confirmed Stage 0-III breast cancer at time of diagnosis.
* Participant must have completed primary treatment 1-10 years prior to Step 0 registration.
NOTE: Current hormonal therapy is allowed. NOTE: Primary treatment can include chemotherapy and/or surgery and/or radiation therapy.
\- Participant must be receiving their care (cancer treatment or survivorship care) from an oncology provider affiliated with the NCORP site and are expected to continue care at the site for the next 18 months.
NOTE: This eligibility criteria is intended to ensure access to healthcare utilization data. Oncology provider can include an Advance Practice Provider, Advance Nurse Practitioner, oncologist, primary care provider, or nurse or physician responsible for survivorship care.
* Participant must have no evidence of active cancer of any type at the time of Step 0 registration (per the assessment of the physician), excluding local basal cell or squamous cell carcinoma.
* Participant must be fluent in written and spoken English.
* Participant must have an ECOG Performance Status of 0-2.
* Participant must have the ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) are not eligible.
* Participant must complete the FCRI 9-item severity scale and report a score of 13 or higher.
* Participant must have access to the internet (via smartphone, tablet, or computer).
NOTE: The restriction to those with internet access is based on the primary intention of the study which involves internet-based delivery intervention content delivered via the internet.
* Participant must have completed the Baseline Assessment within 60 days of Step 0 registration.
* Randomization to Step 1 must occur within 60 days of Step 0 registration.
Exclusion Criteria:
* Participant must not have any psychiatric or cognitive conditions that may affect the participant's ability to accurately provide self-report data, per clinical discretion.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07122492
Study Brief:
Protocol Section:
NCT07122492