Clinical trial NCT02529280: Choices for Latinas and Clinical Trials
Official title: Choices: Increasing Access of Latinas Into Breast Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Latinas
Breast Cancer
Clinical Trials
Participation
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study features a cohort design with random assignment of 112 Latina breast cancer patients from the CTRC to an intervention (56) or usual care control group (56). The intervention group will receive three components: 1) a culturally sensitive and individually tailored, 30-minute computer-based BCCT educational video; 2) a bilingual, low literacy booklet that encourages patients to communicate with family and friends; and 3) support from a patient navigator. The usual care control group will receive usual care breast cancer clinical trial information materials offered by the CTRC to its eligible patients. The intervention is based in two proven theories - Stages of Change and Social Cognitive Theory - and will feature basic components of individual empowerment, including knowledge, attitudes, skills and self-efficacy beliefs and expectations.

The study has three main phases: Phase 1: Formative Research; Phase 2: Intervention; and Phase 3: Evaluation.

Purpose:

To empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs) by enhancing their knowledge, attitudes, skills and self-efficacy required to support discussion of CT as a treatment option with doctors and family members.

Specific Objectives:

1. Increase patient education and awareness, positive attitudes and self-efficacy to enhance their decision-making skills to participate in BCCTs.
2. Provide decisional support to make an informed decision regarding participation in BCCTs by encouraging discussion of BCCTs as a treatment option with medical team, family and friends.
3. Test the efficacy of a multi-communication intervention to assist Latina breast cancer patients in their decision making process regarding participation in BCCTs.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Non-Hispanic women
* Children
* Men

Primary outcomes:
measure: Attitudes towards clinical trials
timeFrame: Baseline and post intervention survey within 3 months from baseline
measure: Self-efficacy
timeFrame: Baseline and post intervention survey within 3 months from baseline
measure: Enrollment in a Clinical Trial
timeFrame: within 6 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center - CTRC
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Amelie G. Ramirez, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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]