Promoting Breast Cancer Screening in Non-adherent Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36,348
- 试验地点
- 1
- 主要终点
- The proportion of women in each arm who complete a mammogram in the prior 24 months
研究概览
简要总结
This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods of reaching out to women who are coming due for or who are overdue for a mammogram. The study originally embedded in a community healthcare plan and an associated community clinic, now accepts patients using the community clinic and 3 other health care plans. The study makes use of a complex computer driven reminder system.
The study also will examine ways to improve the efficiency and sequencing of the interventions by identifying patient factors associated with intervention effectiveness.
详细描述
The randomized study compares three interventions. All eligible women are randomly assigned to 1 of 3 interventions. If they become 18 or more months from a prior mammogram, they will receive the intervention to which they were assigned.
The 3 arms are
- RL ARM: (reminder letter) a control arm which consists of a reminder letter only that states when the last mammogram was, contains a standard recommendation from her primary care provider (PCP), and requests that the woman call a special number for help scheduling a mammogram.
- RC ARM: (reminder call) a reminder letter as above, followed, if no response, by a reminder call from a study scheduler who offers to help schedule a mammogram.
- ETTC ARM: (enhanced tailored telephone counseling call) a reminder letter as above, followed, if no response by a second letter, a mammography educational booklet and a second request to call a special number to schedule a mammogram. If no response, a study counselor/educator will call.
A complex computer-based tracking system identifies women coming due for a mammogram or those overdue for a mammogram. The system interfaces with the clinic database systems and stores information re age, telephone number, address, prior screening dates, primary care provider name, scheduling dates, etc. The system can generate reminder letters as appropriate.
The tracking system also interfaces with computer-assisted telephone script systems(CATI) which prompt the study scheduler or the study counselor to follow the protocol that is tailored to the individual patient.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 40 through 84 years old
- •in the Fallon Community Health Plan, Blue Cross, Tufts or Harvard Pilgrim health plans for 18 or more months
- •has a current Reliant Medical Group (formerly called Fallon Clinic) primary care provider
- •has working telephone
排除标准
- •significant cognitive impairment
- •serious illness, precluding screening
- •bilateral mastectomy
- •life expectancy less than 5 years
结局指标
主要结局
The proportion of women in each arm who complete a mammogram in the prior 24 months
时间窗: 4 years
The outcome will be determined for each of the 4 years of intervention. But the main interest will be the outcome measured in the final intervention year because we believe this best illustrates the magnitude of intervention effect that could be achieved in future years.
次要结局
- Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram(4 years)
- A comparison of the number of interventions required per arm(4 years)
- The percent of women in each arm receiving an intervention who will complete a scheduled mammogram(4 years)
研究者
Mary E. Costanza
Study Principal Investigator
University of Massachusetts, Worcester