Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Breast Cancer Screening Clinical Trial

Official title:

Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267110
• Other study ID #: 12371
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: September 15, 2015
• Start date: September 2010
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being preventable, easily detectable, and curable.2-11 Breast screening continues to be underutilized by the general population and especially by traditionally underserved minority populations. Two of the least screened minority groups are American Indians/Alaska Natives (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates for major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality among Latina women.13 While breast cancer screening rates have increased nationally, there has been an increase in the gap in breast cancer screening utilization between individuals from minority versus majority racial/ethnic groups.

Description:

If you decide to participate in the program, your participation will last 4 months. You will complete the Healthy Living Kansas-Breast Health survey by computer. The survey will take about 20 minutes to complete. You will be randomly assigned (like flipping a coin) to one of two groups. The groups will receive different breast health information. After completing the survey, you agree to be contacted by telephone in 4 months to answer questions. You will be asked for your name, home address, and phone number.

You will be given information about breast cancer and mammography. You may or may not benefit from the information provided. Care will be taken to safeguard the information you provide but under rare circumstances confidentiality breaches may occur.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Latina or AI/AN woman residing in one of participating communities

• Aged =40 years of age

• Not up to date on mammography screening

• Home address & access to a working telephone

• Responded to 120-day post randomization follow-up call

Exclusion Criteria:

• Receipt of mammogram within past year

• Acute medical illness, history of breast cancer, 1st

• Cognitive impairment or inappropriate affect or behavior

• Another household member enrolled in the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer Screening

Intervention

Other:
• MI2 intervention arm
For persons who are randomized to the MI2 intervention arm, the HLK-BH program will guide participants through a series of questions to fully delineate step-by-step breast cancer screening intentions of participants the when, where and how of screening)and encourage follow through on these intentions.
• Control
Each participant in the C intervention arm will receive the same brief one-on-one breast cancer screening education information delivered in person by a CHW as MI2 participants. In additional participants will go through the Healthy Living Kansas-Breast Health computerized screening and intervention program.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	120-day post randomization mammography screening completion	To compare the 120-day post randomization mammography screening completion rates of individuals who receive a computerized mammography "implementation intentions" (MI2) intervention, versus a comparison computerized condition of general breast cancer prevention health education (C).	day 120	No
Secondary	To compare the screening mammography self-reported barriers after 120-days post randomization	To compare the screening mammography self-reported barriers after 120-days post randomization between those receiving a mammography "implementation intentions" intervention (MI2) and those receiving only a general breast cancer prevention health education intervention (C).	day 120	No
Secondary	To compare changes in mammography screening Precaution Adoption Process Model	To compare changes in mammography screening Precaution Adoption Process Model decisional stage from baseline to 120 days post randomization between individuals in the MI2 and C study arms.	day 120	No