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A Sustainable Approach to Increasing Cancer Screening (CATCH)

Primary Purpose

Colorectal Cancer, Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVR only
IVR+PCC
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring screening, cancer prevention, IVR

Eligibility Criteria

21 Years - 86 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Greater Lawrence Family Health Center (GLFHC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control

IVR only

IVR+PCC

Arm Description

Care as usual is given.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 9, 2011
Last Updated
February 18, 2019
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01395459
Brief Title
A Sustainable Approach to Increasing Cancer Screening
Acronym
CATCH
Official Title
A Sustainable Approach to Increasing Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Breast Cancer, Cervical Cancer
Keywords
screening, cancer prevention, IVR

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Care as usual is given.
Arm Title
IVR only
Arm Type
Experimental
Arm Description
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.
Arm Title
IVR+PCC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IVR only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IVR+PCC
Intervention Description
Interactive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR
Primary Outcome Measure Information:
Title
Change in population level cancer screening level at the health clinics involved.
Description
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.
Time Frame
year 3 of the study
Other Pre-specified Outcome Measures:
Title
For the substudy: return rate of gFOBT kits vs. FITs
Description
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.
Time Frame
starting 4-6 weeks post pick up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Emmons, PhD
Organizational Affiliation
Dana-Farber Cancer Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Lawrence Family Health Center (GLFHC)
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01841
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21728056
Citation
Emmons KM, Cleghorn D, Tellez T, Greaney ML, Sprunck KM, Bastani R, Battaglia T, Michaelson JS, Puleo E. Prevalence and implications of multiple cancer screening needs among Hispanic community health center patients. Cancer Causes Control. 2011 Sep;22(9):1343-9. doi: 10.1007/s10552-011-9807-7. Epub 2011 Jul 5.
Results Reference
background
PubMed Identifier
24625364
Citation
Greaney ML, De Jesus M, Sprunck-Harrild KM, Tellez T, Bastani R, Battaglia TA, Michaelson JS, Emmons KM. Designing audience-centered interactive voice response messages to promote cancer screenings among low-income Latinas. Prev Chronic Dis. 2014 Mar 13;11:E40. doi: 10.5888/pcd11.130213.
Results Reference
background

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A Sustainable Approach to Increasing Cancer Screening

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