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Trial record 6 of 7 for:    (arctic OR alaska) AND (native OR tribal) AND (woman OR women OR female)

Engaging Diverse Underserved Communities to Bridge the Mammography Divide

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kimberly Engelman, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT01267110
First received: December 21, 2010
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer Screening
Other: MI2 intervention arm
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 120-day post randomization mammography screening completion [ Time Frame: day 120 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • To compare the screening mammography self-reported barriers after 120-days post randomization [ Time Frame: day 120 ] [ Designated as safety issue: No ]
    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).

  • To compare changes in mammography screening Precaution Adoption Process Model [ Time Frame: day 120 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 242
Study Start Date: September 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Active Comparator: Control Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267110

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Kimberly Engelman, PhD University of Kansas
  More Information

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimberly Engelman, PhD, Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01267110     History of Changes
Other Study ID Numbers: 12371
Study First Received: December 21, 2010
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014