A Sustainable Approach to Increasing Cancer Screening (CATCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Emmons, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01395459
First received: July 9, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

Parent study:

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.

Substudy:

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.


Condition Intervention
Colorectal Cancer
Breast Cancer
Cervical Cancer
Behavioral: IVR only
Behavioral: IVR+PCC

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 13675
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

Substudy methods/design/arms/eligibility:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395459

Locations
United States, Massachusetts
Greater Lawrence Family Health Center (GLFHC)
Lawrence, Massachusetts, United States, 01841
Sponsors and Collaborators
Harvard School of Public Health
Investigators
Principal Investigator: Karen M Emmons, PhD Dana-Farber Cancer Institution
  More Information

No publications provided

Responsible Party: Karen Emmons, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01395459     History of Changes
Other Study ID Numbers: 15622, R01CA126596
Study First Received: July 9, 2011
Last Updated: September 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Harvard School of Public Health:
screening
cancer prevention
IVR

Additional relevant MeSH terms:
Colorectal Neoplasms
Uterine Cervical Neoplasms
Breast Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014