跳至主要内容
临床试验/NCT01395459
NCT01395459已完成不适用

A Sustainable Approach to Increasing Cancer Screening

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 13,675 人开始时间: 2008年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13,675
试验地点
1
主要终点
Change in population level cancer screening level at the health clinics involved.

研究概览

简要总结

Parent study:

A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of two intervention arms (described below) intended to increase breast, cervical, and colon cancer screening rates among patients served by community health centers. A central focus of CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among populations facing significant cancer disparities.

CATCH was conducted in partnership with the large health clinic in Massachusetts, which serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice Response (IVR) telephone technology system, the study is examining the extent to which the IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be conducted to inform the intervention), can improve breast, cervical and colon cancer screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR with telephone calls from a prevention care coordinator (PCC) will result in higher screening rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR alone vs. IVR + PCC.

Substudy:

We conducted a substudy of the parent study, looking at a comparison of return rates of two colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of tests to assess barriers and facilitators of returning the completed kit to the health center for assessment.

详细描述

For the substudy, the study objective was to:

Determine if there is a difference in completion of a home blood stool test kit by type of home test being employed Fecal Occult Blood Test (gFOBT) vs. Fecal Immunochemical Test (FIT), and to determine predictors of test completion.

Substudy methods/design/arms/eligibility:

All patients who picked up a home blood stool test kit during the 6-12 month study recruitment time period were randomized to receive either a gFOBT or FIT kit. Randomization occurred by the month. Medical assistants (MAs) handed out the kits. Participants who picked up a kit (either gFOBT or FIT) were given a study information card that briefly described the study and had a study opt out phone number on it. If patients did not call and opt out, the card let the patient know that he/she would be contacted via telephone to complete a brief survey, for which they were given a small incentive upon completion.

A bilingual member of the study staff telephoned individuals, who had not opted out, who picked up a home blood stool test kit during the study period. Four to six weeks post kit pickup, staff determined if the patient had returned a completed test to the clinic (yes vs. no) by examining the electronic medical record. This information- whether a patient had/had not returned a completed test was used to tailor some questions asked on the survey. Study staff obtained verbal informed consent before survey administration. Participants who cited that time was a burden stopping them from starting the survey were offered an abbreviated version of the survey.

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
21 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Parent study only (please see detailed description for substudy)
  • •Inclusion criteria
  • •All age and gender eligible patients, using GLFHC's guidelines, in need of: breast, cervical or colorectal cancer screenings.

排除标准

  • •All GLFHC patients who do are not age or gender eligible for a breast, cervical or colorectal cancer screening.
  • •Substudy only: Inclusion: age eligible clinic patients who pick up either a gFOBT or FIT kit during the study period. Exclusion: non-age eligible patients who pick up a home test kit.

研究组 & 干预措施

control

No Intervention

Care as usual is given.

IVR only

Experimental

The participants in this study arm receive calls from an Interactive Voice Response (IVR) call system, to remind them that they are in need of breast, cervical and colon cancer screening, as applicable.

干预措施: IVR only (Behavioral)

IVR+PCC

Experimental

The participants in this study arm receive calls from an Interactive Voice Response (IVR) call system, to remind them that they are in need of breast, cervical and colon cancer screening, as applicable. Furthermore, if remained unscreened, these participants receive person to person follow up telephone calls from a prevention care coordinator (PCC) to address barriers.

干预措施: IVR+PCC (Behavioral)

结局指标

主要结局

Change in population level cancer screening level at the health clinics involved.

时间窗: year 3 of the study

The primary outcome of interest is improvement of population-level screening and individual outcomes for 3 cancers (breast, cervical, and colorectal)of patients reached during the intervention.

次要结局

未报告次要终点

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Emmons

Principal Investigator

Harvard School of Public Health (HSPH)

研究点 (1)

Loading locations...

相似试验