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BreastcancerNCT02964234

Empowering Latinas to Obtain Breast Cancer Screenings

A study testing Empowerment and Education in people with Breastcancer and Breast Diseases, run by University of Illinois Chicago 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

The participatory-based project will quantify the 'added benefit' of an empowerment intervention relative to an education intervention for 150 Latinas on the following outcomes: women's adherence to breast cancer screening guidelines; women's psychosocial facilitators (self-efficacy, norms, support, and knowledge)… Read more about this study

Who is it for?
Ages 52 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breastcancer, Breast Diseases
What is being tested?
Empowerment and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
3 sitesUnited States
Study dates
1 Mar 2017to 31 Aug 2021
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 52 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 52-75 years old;
  • Identification as Latina/Hispanic/Chicana female;
  • Residence in Pilsen, Little Village, East Side or South Chicago;
  • No history of health volunteerism;
  • No history of breast cancer; and
  • Lack of a mammogram within the last two years

Who cannot join

  • Not meeting all inclusion criteria;
  • Women will be excluded if they participated in formative focus groups

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • The Resurrection Project

    Chicago, Illinois, 60608

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Juan Diego Centro Comunitario

    Chicago, Illinois, 60617

Other trials in United States

About this study

The participatory-based project will quantify the 'added benefit' of an empowerment intervention relative to an education intervention for 150 Latinas on the following outcomes: women's adherence to breast cancer screening guidelines; women's psychosocial facilitators (self-efficacy, norms, support, and knowledge); and women's dissemination of breast health messages throughout their social network. The empowerment intervention will train Latinas in how to discuss breast health with their family and friends and volunteer in local breast health promotion programs. Academic, clinician, and community partners will work together throughout intervention development and evaluation.

Read the detailed description

Latinas suffer disproportionately from breast cancer relative to non-Latina Whites (NLWs), including late stage detection. While there have been controversies in breast cancer screening, non-adherence to guideline-concordant screening continues to be a major modifiable determinant of breast cancer outcome disparities. Thus, increasing participation in breast cancer screening among Latinas, especially care that corresponds with clinical and academic guidelines, is a public health priority. Participatory approaches are popular methods to improve screening within this group and have included approaches that 1) deliver education to non-adherent Latinas and 2) train community health advocates (community health workers, breast cancer survivors) to engage in breast health promotion. The second approach (empowerment interventions) concerns training participants to engage in social outreach (e.g., having conversations with family and friends about breast health) and volunteering (e.g., helping in health fairs, engaging in civic campaigns about breast cancer programs). Patient activation and volunteerism literature suggest that empowerment interventions may have 'added value' for participants themselves over delivering education in terms of preventive health psychosocial factors and practices. Relative to education interventions, empowerment interventions may also affect women's networks, as they may be more likely to disseminate evidence-based breast health promotion among their family and friends. To date, little research has compared interventions' effects on individual-level outcomes or used formal social network analysis to examine network effects. The proposed work adds to the literature through empirically comparing two approaches (education versus empowerment) on three sets of outcomes: 1) women's own screening, 2) women's own self-efficacy, norms, support, knowledge; and 3) women's networks (measured by egocentric analysis). I will lead this work and will benefit from the collective expertise and resources of my mentors (Drs. Ferrans, Mermelstein, Geller) and collaborators (Dr. Schneider, The Resurrection Project, Metropolitan Chicago Breast Cancer Task Force, Sinai Urban Health Institute, University of Illinois Cancer Center). Aim 1 intervention development will be accomplished through continuous stakeholder engagement and specifically through meetings and focus groups with a bilingual, bicultural community advisory engagement board (CEAB), UICC radiologists and target participants (non-adherent Latinas). We have already begun this process and are obtaining formative data. After we develop intervention materials, a pilot trial will be conducted with an area-level treatment control group design in Chicago. Participants will be 150 Latinas with no history of health volunteerism, residence in one of two targeted areas, and non-adherence to US Preventive Services Task Force screening guidelines. Aim 1 intervention evaluation will involve an analysis to compare differences in receipt of a medical record-confirmed screening within six months of participating in the study. Aim 2 will be an analysis to compare interventions' effects on self-efficacy, norms, support, knowledge across three time points - pre-intervention, immediately post-intervention, and six months post-intervention. Aim 3 will be a social network analysis, specifically egocentric, to compare interventions' effects on breast health, network size, and network density as well as will number of peers referred to the study.

Being tested
Empowerment, Education
Keywords
Mammography Screening, Latinas, Breast cancer disparities
Medical subject headings
Breast Diseases

What participants receive

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

  • EmpowermentBehavioural

    Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks

  • EducationBehavioural

    Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks

Study groups in NCT02964234
Study groupRoleWhat they receive
EmpowermentExperimentalBehavior: Empowerment
Receives: Behavioral: Empowerment
EducationExperimentalBehavior: Education
Receives: Behavioral: Education

What is being measured

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

  1. Number of Participants Who Have Obtained Breast Cancer Screening

    Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)

    Measured: 6 months

Timeline

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

  1. First posted16 Nov 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion24 Jul 2019
  4. Study completion31 Aug 2021

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964234
Sponsor's protocol ID
2015-1246
Other IDs
K01CA193918
Status last verified
Nov 2021
First submitted
11 Nov 2016
Last updated
18 Nov 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After major study findings have been accepted for publication, Dr. Molina will develop an anonymized data set (i.e., no personally identifiable information) available to qualified scientists upon request. Data will only be made available to scientists who complete a data-sharing agreement that indicates: 1) commitment to using the data only for research purposes and not to identify any individual participant; 2) commitment to securing data using appropriate computer technology; and 3) commitment to destroying or returning the data after analyses are completed.

Questions about this trial

What is this clinical trial studying?

A study testing Empowerment and Education in people with Breastcancer and Breast Diseases, run by University of Illinois Chicago 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 6 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 18 Nov 2021. 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 26 May 2020). 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?

Number of Participants Who Have Obtained Breast Cancer Screening (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Nov 2021.

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