Breast Cancer
Conditions
Keywords
Latinas, Breast Cancer, Clinical Trials, Participation
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.
Interventions
BEHAVIORALIntervention
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.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attitudes towards clinical trials | Baseline and post intervention survey within 3 months from baseline | Eight-item scale measuring attitudes towards clinical trials (staging questions) |
| Self-efficacy | Baseline and post intervention survey within 3 months from baseline | 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. |
| Enrollment in a Clinical Trial | within 6 months from baseline | Participants' medical records will be reviewed to determine enrollment in a CT |
Countries
United States
Outcome results
None listed