NCT01395459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,675

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

July 9, 2011

Last Update Submit

February 18, 2019

Conditions

Keywords

screeningcancer preventionIVR

Outcome Measures

Primary Outcomes (1)

  • 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.

    year 3 of the study

Other Outcomes (1)

  • For the substudy: return rate of gFOBT kits vs. FITs

    starting 4-6 weeks post pick up

Study Arms (3)

control

NO INTERVENTION

Care as usual is given.

IVR only

EXPERIMENTAL

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

IVR+PCC

EXPERIMENTAL

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

Interventions

IVR onlyBEHAVIORAL

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.

IVR only
IVR+PCCBEHAVIORAL

Interactive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR

IVR+PCC

Eligibility Criteria

Age21 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All age and gender eligible patients, using GLFHC's guidelines, in need of: breast, cervical or colorectal cancer screenings.

You may not qualify if:

  • All GLFHC patients who do are not age or gender eligible for a breast, cervical or colorectal cancer screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Lawrence Family Health Center (GLFHC)

Lawrence, Massachusetts, 01841, United States

Location

Related Publications (2)

  • 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.

    PMID: 21728056BACKGROUND
  • 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.

    PMID: 24625364BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Karen M Emmons, PhD

    Dana-Farber Cancer Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2011

First Posted

July 15, 2011

Study Start

September 1, 2008

Primary Completion

March 1, 2011

Study Completion

October 1, 2013

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations