Breast Cancer ScreeningNCT01267110
Engaging Diverse Underserved Communities to Bridge the Mammography Divide
A study testing MI2 intervention arm in people with Breast Cancer Screening, run by University of Kansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- MI2 intervention arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Breast Cancer Screening
- Being tested
- MI2 intervention arm, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI2 intervention armOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: MI2 intervention arm |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 120
Secondary outcomes (2)
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).
Measured: 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.
Measured: day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Engelman, PhD, University of Kansas
- Investigators
- Kimberly Engelman, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267110
- Sponsor's protocol ID
- 12371
- Status last verified
- Sep 2015
- First submitted
- 21 Dec 2010
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21255424
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Diverse Underserved Communities to Bridge the Mammography Divide
- ClinicalTrials.gov ID
- NCT01267110
- Acronym / sponsor ID
- 12371
- Conditions
- Breast Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MI2 intervention arm |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI2 intervention armFor 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. | Other | Intervention |
| ControlEach 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. | Other | Control |
Primary outcome
120-day post randomization mammography screening completion
Time frame: day 120
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).
2 secondary outcomes
To compare the screening mammography self-reported barriers after 120-days post randomization
Time frame: day 120
To compare changes in mammography screening Precaution Adoption Process Model
Time frame: day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Derived from this study: PubMed 21255424Engelman 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.
Related trials for Breast Cancer Screening
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Enrolling by invitationObservational study
Early Detection of Breast Cancer Among Syrian Women
Breast Cancer Detection
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Engelman, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI2 intervention arm in people with Breast Cancer Screening, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
120-day post randomization mammography screening completion (time frame: day 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.