A prospective study of breast cancer survivorship in Kaiser Permanente Northern California: The Pathways study.

A149

With over two million breast cancer survivors in the U.S. today, identification of modifiable factors associated with recurrence and survival is becoming increasingly important. Assessment of these factors is in its infancy, with most prior studies converting cancer etiology studies into prognosis studies. Only recently have new studies been designed to specifically examine the impact of lifestyle factors on prognosis. One such study is Pathways, a prospective study of breast cancer survivors in Kaiser Permanente Northern California (KPNC). The aims are to examine the effect on recurrence and survival of 1) lifestyle factors such as diet, physical activity, quality of life, and use of complementary and alternative therapies and 2) molecular factors such as genetic polymorphisms involved in metabolism of chemotherapeutic agents and aberrant DNA methylation within breast tumors. Eligibility includes any woman diagnosed with invasive breast cancer within KPNC, no previous diagnosis of other invasive cancer, age ≥ 21 years, and ability to speak English, Spanish, Cantonese, or Mandarin. Newly-diagnosed breast cancer patients are identified daily from electronic pathology records and verified by review of electronic charts. The physician of record is notified by email and asked to respond within one week if the patient should be excluded. A recruitment letter is then mailed, followed by a phone call from a field interviewer who schedules a baseline appointment. Women are enrolled within two months of diagnosis. An extensive baseline interview is conducted, blood and saliva samples are collected, and body measurements are taken. Beginning this fall, tumor tissue samples will be obtained for each participant. Women will be followed for lifestyle updates, treatment, and outcomes by self-report every 6 to 12 months, query of KPNC databases, and chart review. Recruitment began in early 2006, and as of 14 September 2006, out of 1,114 sent a letter and with a known status, 76 (7%) were unreachable by telephone, 192 (17%) were ineligible, and 297 (27%) refused. The remaining 549 (49%) were scheduled for a baseline appointment, of whom 459 (84%) completed the baseline interview and enrolled in the study. As for biospecimen collection, 384 blood samples (84% of enrolled women) and 417 saliva samples (91%) have been obtained. The blood is aliquoted into straws and cryovials of plasma, serum, buffy coat, and red blood cells and stored for future laboratory analyses. The saliva serves as the back-up source of DNA for participants who did not consent to the blood draw. Data collection will continue through June 2009 and beyond pending further funding. The Pathways Study should become a rich data resource of behavioral and molecular factors and breast cancer prognosis. Funded by the National Cancer Institute (CA105274).