Behavioral and Psychological Impact of Returning Breast Density Results to Latinas

NCT02910986 | Completed Results

• 3 other identifiers: 16-003707R01MD009682MC1936
• Study Type: interventional
• Target: 1,386
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

Mammography; Breast Density; Hispanic

Outcome Measures

Primary Outcomes (3)

• Knowledge of Breast Density as a Masking Factor at First Follow-up

  Percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response at T1 Comparisons of the difference between the intervention groups in percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response to the question at T1

  Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)

• Anxiety Short Term (Baseline T0 to First Follow-up T1)

  The State-Trait Anxiety Inventory-State (STAI-S) s a 20-item self-report assessment. Items are answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so), with the total score ranging from 20 to 80, with higher scores indicating higher levels of anxiety symptoms. Anxiety was dichotomized as: normal (STAI score \< 30) or moderate to severe (STAI score ≥ 30). The primary outcome was the percentage of participants who maintained or decreased to 'normal' anxiety levels at T1 from T0.

  Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end

• BC Risk Assessment - Survey

  Percentage of women who provided incorrect response at baseline (T0) but a correct response at 14 to 180 days after completion of education to the question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know). Comparisons of the difference in percentage of women who provided correct response to the single question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know) between intervention groups.

  T0 (baseline) to T1 (14 to 180 days after completion of education)

Study Arms (3)

Usual Care

NO INTERVENTION

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

Enhanced

ACTIVE COMPARATOR

Usual Care plus a written educational brochure

Behavioral: Written educational brochure

Interpersonal

ACTIVE COMPARATOR

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

Behavioral: Written educational brochure; Behavioral: Promotora interaction

Interventions

Written educational brochure BEHAVIORAL

Written educational brochure about breast density

Enhanced; Interpersonal

Promotora interaction BEHAVIORAL

Promotora education about breast density

Interpersonal

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Male
• Current diagnosis of breast cancer

Sponsors & Collaborators

• Mayo Clinic: lead
• Mountain Park Health Center: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Mountain Park Health Center

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

• 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.

  PMID: 34855208 RESULT

• Patel BK, Ridgeway JL, Jenkins S, Rhodes DJ, Ghosh K, Borah B, Suman V, Norman A, Leaver J, Jewett M, Hruska C, Gonzalez C, Singh D, Vachon CM, Breitkopf CR. Breast Density Knowledge and Awareness Among Latinas in a Low-Resource Setting. J Am Coll Radiol. 2022 Jan;19(1 Pt B):155-161. doi: 10.1016/j.jacr.2021.08.025.

  PMID: 35033304 RESULT

• Austin JD, Jenkins SM, Suman VJ, Raygoza JP, Ridgeway JL, Norman A, Gonzalez C, Hernandez V, Ghosh K, Patel BK, Vachon CM. Breast Cancer Risk Perceptions Among Underserved, Hispanic Women: Implications for Risk-Based Approaches to Screening. J Racial Ethn Health Disparities. 2025 Apr;12(2):1150-1158. doi: 10.1007/s40615-024-01949-7. Epub 2024 Feb 21.

  PMID: 38383839 RESULT

• Ghosh K, Jenkins SM, Ridgeway JL, Austin JD, Borah BJ, Patel B, Rhodes DJ, Norman AD, Ramos EP, Jewett M, Gonzalez CR, Hernandez V, Singh D, Vachon CM, Suman VJ. A randomized trial to evaluate the impact of breast density notification on anxiety, breast cancer worry, and perceived risk among Latinas at a federally qualified health center : Breast density notification and anxiety, breast cancer worry, and perceived risk among Latinas. BMC Womens Health. 2025 Jun 2;25(1):274. doi: 10.1186/s12905-025-03818-9.

  PMID: 40452038 DERIVED

• 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.

  PMID: 31852492 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Celine M. Vachon, Ph.D.
• Organization: Mayo Clinic

Vachon.Celine@mayo.edu

507 293-3247

Study Officials

• Celine M. Vachon, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 22, 2016
• Study Start: October 27, 2016
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)