Choices for Latinas and Clinical Trials
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/22/2016 |
| Start Date: | February 2012 |
| End Date: | December 2015 |
Choices: Increasing Access of Latinas Into Breast Cancer Clinical Trials
"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.
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.
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.
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.
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
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