Clinical trial NCT02910986: Latinas Learning About Density
Official title: Latinas LEarning About Density (LLEAD Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Mammography
Breast Density
Hispanic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Mountain Park Health Center
First posted: 2016-09-22
Enrollment: 1386
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine behavioral and psychological outcomes of breast density notification using a 3-group randomized design comparing usual written notification to two educationally enhanced approaches.

Detailed description: This is a 3-group randomized clinical trial to compare usual care to two educationally enhanced approaches to breast density notification. Usual care involves sending written notification along with the mammogram report; all women will receive usual care. In addition, some women will receive written educational materials about breast density, with or without interaction with a promotora (culturally congruent health educator). Study outcomes include short and long term assessments of psychological (anxiety, knowledge) and behavioral (continued mammography screening, discussion with primary care provider) outcomes. The study also includes qualitative inquiry and a cost analysis.

Eligibility criteria: Inclusion Criteria:

* Female
* Attending screening mammography at Mountain Park Health Center
* Speak English or Spanish

Exclusion Criteria:

* Male
* Current diagnosis of breast cancer

Primary outcomes:
measure: Anxiety Short Term
timeFrame: Change from baseline anxiety at 1 month
measure: Breast density knowledge
timeFrame: Total knowledge scores at 1 month
measure: Anxiety Longer Term
timeFrame: Change from baseline anxiety at 1 year
Secondary outcomes:
measure: Adherence to mammography screening
timeFrame: 1 year post density notification
Other outcomes:
measure: Intervention cost
timeFrame: 1 year post density notification
Locations:
city: Phoenix
country: United States
facility: Mountain Park Health Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Celine Vachon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ridgeway JL, Jenkins SM, Borah BJ, Suman VJ, Patel BK, Ghosh K, Rhodes DJ, Norman A, Ramos EP, Jewett M, Gonzalez CR, Hernandez V, Singh D, Sosa M, Radecki Breitkopf C, Vachon CM. Evaluating educational interventions to increase breast density awareness among Latinas: A randomized trial in a Federally Qualified Health Center. Cancer. 2022 Mar 1;128(5):1038-1047. doi: 10.1002/cncr.34017. Epub 2021 Dec 2.
citation: Patel BK, Ridgeway JL, Ghosh K, Rhodes DJ, Borah B, Jenkins S, Suman VJ, Norman A, Jewett M, Singh D, Vachon CM, Radecki Breitkopf C. Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial. Trials. 2019 Dec 18;20(1):744. doi: 10.1186/s13063-019-3939-6.