Breast Cancer Clinical Trial
Official title:
A Sustainable Approach to Increasing Cancer Screening
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.
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.
This study was limited to age eligible patients who picked up a home colon cancer screening
kit.
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