Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Conditions
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Breast Cancer Screening

Intervention / Treatment
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* Other: MI2 intervention arm
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: MI2 intervention arm<br>* 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.<br>|
| Active Comparator: Control<br> | Other: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |