Ignite Creation Date:
2024-05-06 @ 7:24 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02529280
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2015-08-11
Brief Title:
Choices for Latinas and Clinical Trials
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Choices Increasing Access of Latinas Into Breast Cancer Clinical Trials
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US population but only 56 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None