Behavioral and Psychological Impact of Returning Breast Density Results to Latinas

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Written educational brochure; Behavioral: Promotora interaction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02910986

R01MD009682 (U.S. NIH Grant/Contract)

16-003707

MC1936 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,386 patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Male
• Current diagnosis of breast cancer

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,386 participants in 3 patient groups

Usual Care

No Intervention group

Description:

Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter

Enhanced

Active Comparator group

Description:

Usual Care plus a written educational brochure

Treatment:

Behavioral: Written educational brochure

Interpersonal

Active Comparator group

Description:

Usual Care plus Enhanced plus interaction with a promotora (lay health educator)

Treatment:

Behavioral: Promotora interaction

Behavioral: Written educational brochure