NCT01267110

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

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, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

4.8 years

First QC Date

December 21, 2010

Last Update Submit

September 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • To compare the screening mammography self-reported barriers after 120-days post randomization

    day 120

  • To compare changes in mammography screening Precaution Adoption Process Model

    day 120

Study Arms (2)

Intervention

EXPERIMENTAL
Other: MI2 intervention arm

Control

ACTIVE COMPARATOR
Other: Control

Interventions

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.

Intervention
ControlOTHER

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.

Control

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Engelman KK, Cupertino AP, Daley CM, Long T, Cully A, Mayo MS, Ellerbeck EF, Geana MV, Greiner A. Engaging diverse underserved communities to bridge the mammography divide. BMC Public Health. 2011 Jan 21;11:47. doi: 10.1186/1471-2458-11-47.

Study Officials

  • Kimberly Engelman, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 24, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations