July 11 2024
NRG-CC011 activated on February 2, 2024, and is OPEN to accrual. Sites are being approved to participate and beginning to enroll participants to the study. Our goal is to recruit 386 breast cancer survivors with substantial cognitive concerns. We encourage all sites, especially our community and minority sites, to join our study to address cancer related cognitive impairment.
To minimize site burden: a Screening Script is available on the CTSU website under NRG-CC011 – CIRB Approved Documents Support Documents – Screening Script (Version 11/30/23) which will streamline your review of potentially eligible participants. The script will save you and the potential participant time -- ask participants if they have cognitive concerns and are interested in the study – if yes, proceed with verbal consent to complete the screening questionnaires; if the answer is no, you should not proceed with verbal consent or further screening.
The following eligibility and ineligibility criteria will be clarified in a future amendment, at which time will be implemented for sites to use when screening participants.
1. Clarification to Eligibility Criteria Section 3.2.5: Breast cancer survivors with ≥ 6 months to 5 years post-treatment [(completion of initial surgery +/- adjuvant chemotherapy/radiation therapy and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy)] may still be taking endocrine therapy and/or trastuzumab.
2. Clarification to Eligibility Criteria: Eligible participants must be able to see and hear adequately with assistive devices (i.e., glasses and hearing aids) in order to complete assessments over the phone and completing the online computerized training.
3. Clarification to Ineligibility Section 3.3.9: Breast cancer survivors who are enrolled in the active intervention (behavioral or pharmaceutical) or follow-up phase of a cancer control protocol or other therapeutic trial that has extensive PRO follow-up after treatment ends and/or quality of life trials. However, please note: Patients who are enrolled in a therapeutic trial in which they have completed active treatment and require only minimal follow-up monitoring of toxicity and/or survival analysis (cancer-related mortality or all-cause mortality) would be eligible.
Optimal Screening time: If you know of a potentially eligible breast cancer survivor who could benefit from the trial but is still in active treatment and/or has other medical or non-medical issues that would prohibit participation, please wait to screen until those temporary issues have resolved. Once a potentially eligible participant has been screened and found not eligible, that individual breast cancer survivor cannot be re-screened for future participation.
For questions, please e-mail the NRG-CC011 study team at VonAhResearchLab@osu.edu (listed on the cover page of the protocol)