Clinical trial NCT00836303: Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
Official title: A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening Among Latino Immigrants in a Primary Care Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the effectiveness of a culturally-responsive intervention to increase colorectal cancer (CRC) screening among Latino immigrants in a primary care clinic setting of a large municipal Hospital in New York City. propose a randomized, control trial to determine if a video-based intervention, that educates and activates the patient and the provider via the patient, will increase rates of CRC screening referrals compared to a control group.

Colorectal cancer remains one of the most prevalent cancers among the general population, as well as in the Latino population, in the United States. There are serious disparities in CRC screening rates between different races and socio-demographic populations (American Cancer Society: Colorectal Cancer Facts and Figures - Special Edition 2005). Latino immigrants are one of the populations most affected by the lack of screening, reducing their relative benefit from preventive CRC services. This study will use a modified version of an intervention developed and studied by Pignone (11), with changes made to be tailored specifically to the Latino immigrant population. The outcomes measured will include referral for CRC screening and adherence with providers' referrals. In addition, the investigators will measure screening rates for other cancer screening tests to assess if the CRC intervention displaces or facilitates other cancer screening. A sample of Latino immigrants seeking care at the primary care clinic of Bellevue Hospital will be accrued through a process of consecutive sampling until reaching the proposed sample size of 101 patients in each group (alpha 0.05 and power of 80%). To analyze the effectiveness of the intervention the investigators will use the z-test and will report the difference in proportion between the intervention and the control group with a 95% CI, adjusting for intra-class correlations and covariates. A repeated measurement analysis with logistic regression will be used to examine the effects of covariates.


Eligibility criteria: Inclusion Criteria:

* Adult Latino immigrants
* Men and women
* 50 years and older
* Having had at least 2 previous visits to the primary care clinic in the past 2 years

Exclusion Criteria:

* Personal or family history of colorectal cancer.
* Had fecal occult blood testing (FOBT) in the past year, or flexible sigmoidoscopy or barium enema in the past 5 years, or colonoscopy in the past 10 years.
* Lower gastrointestinal symptoms, including bleeding, pain, diarrhea and/or constipation.
* Too ill to participate
* Any cancer diagnosis other than non-melanoma skin cancer.

Primary outcomes:
measure: Completion of Colorectal cancer screening
timeFrame: 3 months
Secondary outcomes:
measure: physician recommendation for colorectal cancer screening
measure: Patient adherence to physician recommended colorectal cancer screening test
timeFrame: 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Francesca M Gany, MD
role: PRINCIPAL_INVESTIGATOR
References: