Choices for Latinas and Clinical Trials
Choices: Increasing Access of Latinas Into Breast Cancer Clinical Trials
1 other identifier
interventional
77
1 country
1
Brief Summary
"Increasing Access of Latinas into Breast Cancer Clinical Trials" aims to develop and pilot test a multi-communications approach - using a culturally relevant computer video, a tailored booklet and a patient navigator (PN) - to empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs). Latinos represent 15% of the U.S. population but only 5.6% of participants in National Cancer Institute (NCI) treatment clinical trials, resulting in disparities in cancer outcomes and jeopardizing the generalizability of trial findings. In response, this study will develop and evaluate communication and health-system-change strategies to facilitate Latinas' access to BCCTs at the Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio (CTRC-UTHSCSA). The CTRC-UTHSCSA, an NCI-designated Cancer Center located in South Texas, serves a culturally and ethnically diverse population that historically has low participation in clinical trials, especially among those with breast cancer, the No. 1 cancer killer of Latinas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Feb 2012
Typical duration for not_applicable breast-cancer
1 active site
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
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
August 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 21, 2016
July 1, 2016
3.8 years
August 11, 2015
July 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Attitudes towards clinical trials
Eight-item scale measuring attitudes towards clinical trials (staging questions)
Baseline and post intervention survey within 3 months from baseline
Self-efficacy
14-item scale measuring self-efficacy regarding seeking information about clinical trials, communication with doctors, family members and friends, confidence in the system, decision making and expectations if enrolled in a clinical trial.
Baseline and post intervention survey within 3 months from baseline
Enrollment in a Clinical Trial
Participants' medical records will be reviewed to determine enrollment in a CT
within 6 months from baseline
Study Arms (2)
Intervention
EXPERIMENTALThe intervention group will receive three components: 1) a culturally sensitive, individually tailored, 30-minute computer-based BCCT video; 2) a bilingual, low-literacy booklet aimed at encouraging patients to communicate with family and friends and 3) assistance from a patient navigator.
Usual Care
NO INTERVENTIONThe usual care control group will receive the usual care breast cancer clinical trial information materials offered by the CTRC to their eligible patients.
Interventions
Intervention includes 1) a 30-minute computer-based video (in English/Spanish), featuring instructional screens, graphics and animation to help participants understand the concepts presented. It will feature breast cancer patients who have participated in CTs, patients talking to their doctor or nurse and a bilingual narrator to guide participants. Video content will address common barriers and concerns regarding clinical trials, as well as the informed consent process, and how clinical trials are monitored and reviewed; 2) a bilingual easy to understand booklet with tailored information on clinical trials. The booklet will include many of the elements and messages featured in the video program; and 3) assistance from a trained, bilingual, bicultural, nurse navigator.
Eligibility Criteria
You may qualify if:
- English and Spanish speaking Latinas diagnosed with breast cancer who: attend the CTRC breast clinic and/or other CTRC clinics, have not had their initial doctor consultation to discuss treatment options, have not participated in a clinical trial before, and are eligible to participate in one of the Phase III, Phase IV or selective Phase II breast cancer clinical trials (BCCT) open at the CTRC at the time of diagnosis.
You may not qualify if:
- Non-Hispanic women
- Children
- Men
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Therapy and Research Center - CTRC
San Antonio, Texas, 78229, United States
Related Publications (1)
Chalela P, Muñoz E, Gallion JK, Karnad A, Ramirez AG. Empowering Latina breast cancer patients to make informed decisions about clinical trials: A multicommunication approach. Cancer Epidemiol Biomarkers Prev 24(10 Suppl), 2015 [abstract]
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amelie G. Ramirez, DrPH
The University of Texas Health Science Center at San Antonio
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, ad interim, and Professor, Department of Epidemiology and Biostatistics
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 20, 2015
Study Start
February 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 21, 2016
Record last verified: 2016-07