New York Prevention Care Manager Project
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,729
- 试验地点
- 2
- 主要终点
- Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
研究概览
简要总结
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.
详细描述
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.
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Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility.
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Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted.
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Part 3: Patients are randomized to 1 of 2 intervention arms.
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Arm I: Patients are offered health education and follow-up services by telephone with a PCM.
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Arm II: Patients receive usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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:
- •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
排除标准
- 未提供
研究组 & 干预措施
Intervention
Series of telephone support calls from a trained prevention care manager
干预措施: educational intervention (Other)
Intervention
Series of telephone support calls from a trained prevention care manager
干预措施: study of socioeconomic and demographic variables (Other)
Usual Care
Usual care
结局指标
主要结局
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
Follow-up patient cancer 3 months after completion of study treatment
次要结局
未报告次要终点