Breast CancerNCT02910986

Behavioral and Psychological Impact of Returning Breast Density Results to Latinas

A study testing Written educational brochure and Promotora interaction in people with Breast Cancer, run by Mayo Clinic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 74 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Written educational brochure and Promotora interaction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,386 participants
Where: 3 sitesUnited States
Study dates: 27 Oct 2016to 15 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 74 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Male
Current diagnosis of breast cancer

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Mountain Park Health Center
Phoenix, Arizona, 85004
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Latinas LEarning About Density (LLEAD Study)

Read the 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.

Conditions: Breast Cancer
Being tested: Written educational brochure, Promotora interaction
Keywords: Mammography, Breast Density, Hispanic
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Written educational brochureBehavioural
Written educational brochure about breast density
Promotora interactionBehavioural
Promotora education about breast density

Study groups in NCT02910986
Study group	Role	What they receive
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 Receives: Behavioral: Written educational brochure
Interpersonal	Active comparator	Usual Care plus Enhanced plus interaction with a promotora (lay health educator) Receives: Behavioral: Written educational brochure; Behavioral: Promotora interaction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 201615 Nov 2019

First posted22 Sep 2016 (estimated)
Study start27 Oct 2016
Primary completion15 Nov 2019
Study completion15 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,386 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02910986
Sponsor's protocol ID: 16-003707
Other IDs: R01MD009682, MC1936
Status last verified: May 2025
First submitted: 8 Sep 2016
Last updated: 28 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 34855208
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.
PubMed 35033304
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.
PubMed 38383839
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.
PubMed 40452038
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.
PubMed 31852492

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Latinas LEarning About Density (LLEAD Study)
ClinicalTrials.gov ID: NCT02910986
Acronym / sponsor ID: 16-003707
Conditions: Breast Cancer
Keywords: Mammography, Breast Density, Hispanic
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,386 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Mountain Park Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 27 Oct 2016 (actual)
Primary completion: 15 Nov 2019 (actual)
Study completion: 15 Nov 2019 (actual)
First posted: 22 Sep 2016 (estimated)
Results: Posted 28 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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	Behavioral: Written educational brochureUsual Care plus a written educational brochure
Interpersonal	Active comparator	Behavioral: Written educational brochure, Behavioral: Promotora interactionUsual Care plus Enhanced plus interaction with a promotora (lay health educator)

Who may qualify

Ages: 40 to 74 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Male
Current diagnosis of breast cancer

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
Written educational brochureWritten educational brochure about breast density	Behavioural	Enhanced, Interpersonal
Promotora interactionPromotora education about breast density	Behavioural	Interpersonal

Primary outcome

Knowledge of Breast Density as a Masking Factor at First Follow-up
Time frame: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)
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
Anxiety Short Term (Baseline T0 to First Follow-up T1)
Time frame: Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end
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.
BC Risk Assessment - Survey
Time frame: T0 (baseline) to T1 (14 to 180 days after completion of education)
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.

Results and safety

Results posted to the registry on 28 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	460	349
Enhanced	456	334
Interpersonal	461	260

Primary outcome: Knowledge of Breast Density as a Masking Factor at First Follow-up

Time frame: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end). Count of participants. Unit: Participants

Measure	Enhanced n = 334	Usual Care n = 349	Interpersonal n = 260
Value	101	104	100

Enhanced vs Usual Care vs Interpersonal: p > 0.05, Chi-squared

Population analysed: 943 participants who completed baseline and first follow-up

Primary outcome: Anxiety Short Term (Baseline T0 to First Follow-up T1)

Time frame: Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end. Count of participants. Unit: Participants

Measure	Usual Care n = 199	Enhanced n = 186	Interpersonal n = 131
Decreased or stayed normal	99	88	70
Increased or stayed moderate/severe	100	98	61

Usual Care vs Enhanced vs Interpersonal: p = 0.56, Chi-squared

Population analysed: 516 Latina participants with complete follow-up over all three time points

Primary outcome: BC Risk Assessment - Survey

Time frame: T0 (baseline) to T1 (14 to 180 days after completion of education). Count of participants. Unit: Participants

Measure	Enhanced n = 334	Usual Care n = 349	Interpersonal n = 260
Value	114	110	95

Enhanced vs Usual Care vs Interpersonal: p > 0.05, Chi-squared
Enhanced vs Usual Care: difference between EC and UC: 2.6 (98.3% CI -6.0 to 11.2)
Usual Care vs Interpersonal: difference between INT and UC: 5.0 (98.3% CI -4.3 to 14.3)

Adverse events

Time frame: Patients completed T1 surveys within 14-180 days from the end of study education and T2 surveys were completed within 275-545 days from the end of study education. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 349 (0%)	0 of 349 (0%)	0 of 349
Enhanced	0 of 334 (0%)	0 of 334 (0%)	0 of 334
Interpersonal	0 of 260 (0%)	0 of 260 (0%)	0 of 260

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34855208Ridgeway 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.
Results publication: PubMed 35033304Patel 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.
Results publication: PubMed 38383839Austin 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.
Derived from this study: PubMed 40452038Ghosh 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.
Derived from this study: PubMed 31852492Patel 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.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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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.

Celine M. Vachon, Ph.D. principal investigator

Mayo Clinic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Written educational brochure and Promotora interaction in people with Breast Cancer, run by Mayo Clinic at 3 sites 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 3 inclusion and 2 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Knowledge of Breast Density as a Masking Factor at First Follow-up (time frame: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)). The study lists 3 primary outcomes in all. 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 NCT02910986, which also lists 5 linked publications.

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 28 Aug 2025.