- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02529280
Choices for Latinas and Clinical Trials
Choices: Increasing Access of Latinas Into Breast Cancer Clinical Trials
Descripción general del estudio
Descripción detallada
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:
- Increase patient education and awareness, positive attitudes and self-efficacy to enhance their decision-making skills to participate in BCCTs.
- 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.
- Test the efficacy of a multi-communication intervention to assist Latina breast cancer patients in their decision making process regarding participation in BCCTs.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Cancer Therapy and Research Center - CTRC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention
The 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.
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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.
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Sin intervención: Usual Care
The usual care control group will receive the usual care breast cancer clinical trial information materials offered by the CTRC to their eligible patients.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Attitudes towards clinical trials
Periodo de tiempo: Baseline and post intervention survey within 3 months from baseline
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Eight-item scale measuring attitudes towards clinical trials (staging questions)
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Baseline and post intervention survey within 3 months from baseline
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Self-efficacy
Periodo de tiempo: Baseline and post intervention survey within 3 months from baseline
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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.
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Baseline and post intervention survey within 3 months from baseline
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Enrollment in a Clinical Trial
Periodo de tiempo: within 6 months from baseline
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Participants' medical records will be reviewed to determine enrollment in a CT
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within 6 months from baseline
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Amelie G. Ramirez, DrPH, The University of Texas Health Science Center at San Antonio
Publicaciones y enlaces útiles
Publicaciones Generales
- 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]
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSC20090165H
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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