A Sustainable Approach to Increasing Cancer Screening (CATCH)

February 18, 2019 updated by: Karen Emmons, Harvard School of Public Health (HSPH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

13675

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lawrence, Massachusetts, United States, 01841
        • Greater Lawrence Family Health Center (GLFHC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Exclusion criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: IVR+PCC
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.
Behavioral: IVR+PCC
Interactive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in population level cancer screening level at the health clinics involved.
Time Frame: 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.
year 3 of the study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
For the substudy: return rate of gFOBT kits vs. FITs
Time Frame: starting 4-6 weeks post pick up
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.
starting 4-6 weeks post pick up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen M Emmons, PhD, Dana-Farber Cancer Institution

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 9, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15622
  • R01CA126596 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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