a telephone-based prevention care manager in increasing screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women

Conditions: Breast Cancer; Cervical Cancer; Colorectal Cancer

Summary: rationale: studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates. purpose: this randomized phase ii trial is studying how well a telephone-based prevention care manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.

objectives: * determine whether telephone support for patients, provided through a prevention care manager (pcm), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women. * measure the amount of pcm time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the new york city area. * learn barriers faced by this population in obtaining indicated services (mammograms, pap tests, fecal occult blood testing, and sigmoidoscopy). * assess at baseline and follow-up the office environment and work processes in each participating center (in pcm randomized controlled study only). * develop and implement the pcm intervention to help patients overcome barriers. * evaluate the impact and costs of the pcm in a randomized controlled efficacy trial. outline: this is a randomized, controlled, single-blind, multicenter study. patients are randomized according to participating center. * part 1: some patients undergo a series of structured interviews about the obstacles to early cancer detection. participating sites are assessed for study eligibility. * part 2: pilot testing, training, and competency testing of the prevention care managers (pcm) are conducted. * part 3: patients are randomized to 1 of 2 intervention arms. * arm i: patients are offered health education and follow-up services by telephone with a pcm. * arm ii: patients receive usual care. projected accrual: a total of 2,729 (1,413 for pcm randomized controlled study and 1,316 for pilot study) patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * patients enrolled in the prevention care manager (pcm) controlled, randomized clinical trial (rct) must meet the following criteria: * registered to receive care at a participating community health center for at least 6 months * overdue for at least one cancer screening as per the following time periods: * no mammography within the past 12 months * no pap test within the past 12 months * no home fecal occult blood test within the past 12 months * no sigmoidoscopy within the past 5 years * no colonoscopy within the past 10 years * must not plan to move out of area or change community health center within 15 months * no unresolved, urgent abnormal cancer screening result found in medical record * patients enrolled in the pcm dissemination pilot study through affinity health plan must meet the following criteria: * enrolled with affinity health plan for at least 12 months * overdue for at least one cancer screening as per the following time periods: * no mammography within the past 2 years * no pap test within the past 3 years * no home fecal occult blood test within the past year for women ≥ 50 years old * no sigmoidoscopy within the past 5 years * no colonoscopy within the past 10 years * must have received care at 1 of 6 participating community health centers in new york city patient characteristics: * female * must not be in acute distress or have an acute illness * age 50 to 69 years for controlled study patients * age 40 to 69 years for pilot study patients prior concurrent therapy: * no concurrent chemotherapy or radiotherapy * no concurrent active cancer treatment * no concurrent palliative care

Keywords: breast cancer cervical cancer colon cancer rectal cancer