A Sustainable Approach to Increasing Cancer Screening (CATCH)
A Coordinated Approach to Cancer and Health (CATCH), is 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 is being 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 will 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.
We are currently conducting 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 are surveying 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.
Behavioral: IVR only
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||A Sustainable Approach to Increasing Cancer Screening|
- Change in population level cancer screening level at the health clinics involved. [ Time Frame: year 3 of the study ] [ Designated as safety issue: No ]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.
- For the substudy: return rate of gFOBT kits vs. FITs [ Time Frame: starting 4-6 weeks post pick up ] [ Designated as safety issue: No ]We are looking at return rates of 2 home colorectal cancer screening tests (gFOBT vs. FIT). We are contacting all people who picked up a kit to assess facilitators and barriers to return.
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
No Intervention: control
Care as usual is given.
Experimental: IVR only
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.
Behavioral: IVR only
As noted, patients in this arm receive consistent, but spaced out calls generated by an interactive voice response system reminding them of breast, cervical and colon cancer screenings needed, as applicable.
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.
Interactive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR
For the substudy, the study objective is 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.
All patients who pick up a home blood stool test kit during the 6-12 month study recruitment time period will be randomized to receive either a gFOBT or FIT kit. Randomization will occur by the month. Medical assistants (MAs) will hand out the kits. Participants who pick up a kit (either gFOBT or FIT) will be given a study information card that briefly describes the study and has a study opt out phone number on it. If patients do not call and opt out, the card lets the patient know that he/she will be contacted via telephone to complete a brief survey, for which they will be given a small incentive upon completion.
A bilingual member of the study staff will telephone all individuals, who have not opted out, who picked up a home blood stool test kit during the study period. Four to six weeks post kit pickup, staff will determine if the patient has returned a completed test to the clinic (yes vs. no) by examining the electronic medical record. This information- whether a patient has/has not returned a completed test will be used to tailor some questions asked on the survey. Study staff will obtain verbal informed consent before survey administration. Participants who cite that time is a burden stopping them from starting the survey will be offered an abbreviated version of the survey.
This study is limited to age eligible patients who pick up a home colon cancer screening kit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395459
|United States, Massachusetts|
|Greater Lawrence Family Health Center (GLFHC)|
|Lawrence, Massachusetts, United States, 01841|
|Principal Investigator:||Karen M Emmons, PhD||Dana-Farber Cancer Institution|