Patterns of Care (POC) Study: Diagnosis Year 2020 (Breast Cancer and Colorectal Cancer)

***Amendment 2 is hereby posted in the Attachments to extend the quote due date from November 1, 2022 to November 8, 2022 at 3:00PM ET. 

 A.        Background

The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted to satisfy a Congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. Therefore, this POC Study shall investigate patterns of care for patients with breast and colorectal cancers, frequently diagnosed cancer sites where care may have been affected by COVID-19 pandemic.  The Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic in the medical record.

B.         Objectives

The primary objectives of this POC Study are to: 1) describe the use of recommended biomarker tests which shall be verified with the treating physician/physician office staff or with a unified  medical record (record with all inpatient and outpatient records in a single file) or complete medical records (all inpatient and outpatient cancer treatment records obtained from more than one hospital/healthcare system/medical practice) and 2) describe the use of targeted therapy which shall be verified with the treating physician/physician office staff or with a unified or complete medical records. Other objectives are to: 3) describe the use of adjuvant therapy, which shall be verified with the treating physician/physician office staff or with a unified or complete medical records; 4) characterize the practice patterns in different communities; 5) compare the patterns of treatment (surgery, radiation therapy, systemic therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, and other adjuvant therapy) over time and by age, sex, race/ethnicity, and insurance status; 6) describe comorbidities and the effect of co-morbid conditions on treatment; 7) describe treatment by hospital characteristics (i.e., for profit vs. not for profit, teaching vs. non-teaching, bed size, etc.); 8) describe the use of diagnostic tests and compare their use by demographic variables; 9) abstract information documented in the medical record on delays or changes in diagnosis, treatment, and supportive/palliative care among individuals diagnosed with cancer specifically due to the COVID-19 pandemic; 10) assess the incidence of cancer recurrence and metastasis following initial diagnosis; and 11) describe medical record documentation of patient financial impacts due to the COVID-19 pandemic potentially affecting cancer care.