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Completed

NCT Number: NCT01395459

A Sustainable Approach to Increasing Cancer Screening

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.

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Key information

Conditions

Colorectal Cancer Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greater Lawrence Family Health Center (GLFHC)

Lawrence, Massachusetts, 01841, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVR only

Behavioral

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+PCC

Behavioral

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

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: CATCH

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Jul 15, 2011
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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