NCT02964234

Brief 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); 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 26, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

November 11, 2016

Results QC Date

April 25, 2020

Last Update Submit

November 16, 2021

Conditions

Keywords

Mammography ScreeningLatinasBreast cancer disparities

Outcome Measures

Primary Outcomes (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)

    6 months

Other Outcomes (2)

  • Changes in Psychosocial Facilitators of Screening Survey Measures

    Baseline and 6 months

  • Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.

    6 months

Study Arms (2)

Empowerment

EXPERIMENTAL

Behavior: Empowerment

Behavioral: Empowerment

Education

EXPERIMENTAL

Behavior: Education

Behavioral: Education

Interventions

EmpowermentBEHAVIORAL

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

Empowerment
EducationBEHAVIORAL

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

Education

Eligibility Criteria

Age52 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women will be excluded if they participated in formative focus groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Resurrection Project

Chicago, Illinois, 60608, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Juan Diego Centro Comunitario

Chicago, Illinois, 60617, United States

Location

MeSH Terms

Conditions

Breast Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Limitations and Caveats

There are several limitations to this study, including a small sample, use of non-probability based sampling strategies, and non-randomization.

Results Point of Contact

Title
Dr. Yamile Molina
Organization
University of Illinois at Chicago

Study Officials

  • Yamile Molina, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 16, 2016

Study Start

March 1, 2017

Primary Completion

July 24, 2019

Study Completion

August 31, 2021

Last Updated

November 18, 2021

Results First Posted

May 26, 2020

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will become available 6 months after publication of the primary outcome papers.
Access Criteria
The study protocol will be shared upon reasonable request by interested researchers. IRB approval will be required before data are released.

Locations