- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04685551
Improving Survivorship Among Minority Cancer Dyads
22 de julio de 2022 actualizado por: Charles Drew University of Medicine and Science
Improving Survivorship Outcomes for African American and Latinx Cancer Survivors and Caregiver Dyads Through A Culturally Based Training Program for Underserved Health Professional Students
This proposed intervention centers on improving survivorship outcomes among African American and Latinx cancer survivor and caregiver dyads.
As a result, there will be four major outcomes.
First, as a result of partnership with minority social institutions (e.g.
faith leaders), we will develop an in-depth culturally sensitive curriculum and survivorship care plan for Cancer Survivorship and Caregiver Leaders Aimed for Minority Populations (CSC LAMPs).
Second, we will increase knowledge and skills by evaluating a comprehensive cancer survivorship training program designed for underserved health professional students.
Third, the implementation of this program will improve survivorship outcomes among African American and Latinx cancer survivors with advanced stage cancer and their caregivers.
Lastly, this study will build sustainability for underserved minorities with the training of 30 future healthcare providers as a valuable community resource for improving cancer survivorship outcomes.
The long-term outcomes of the CSC LAMPs program will generate workforce capacity and diversity in cancer-based clinical practice, research, and community advocacy for underserved minority cancer survivors and caregivers.
Descripción general del estudio
Estado
Retirado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
-
Los Angeles, California, Estados Unidos, 90059
- Charles R. Drew University of Medicine & Science
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Aim 1 Focus Group for Cancer Survivors and Caregivers:
Inclusion Criteria
- Individuals ages 18 and older
- identify as African American or Latinx
- identify as a cancer survivor and/or caregiver
- speak and/or understand English
Exclusion Criteria
- individuals ages 17 years or younger
- does not identify as African American or Latinx
- unable to speak or understand English
- does not identify as a cancer survivor or caregiver
Aim 1 Focus Group for Oncology Healthcare Providers:
Inclusion Criteria
- Individuals ages 18 and older
- identify as a healthcare provider
- provide care to cancer patients in current provider role
- speak and/or understand English
Exclusion Criteria
- individuals ages 17 years or younger
- unable to speak or understand English
- does not provide care to cancer patients
- does not identify as a healthcare provider
Aim 2:
Inclusion Criteria
- Individuals ages 18 and older
- registered as a CDU student
- speak and/or understand English
- considered to be underserved, which include a) identifying as an underrepresented minority: Asian, Pacific Islander, African American, Hispanic, and Native American/Alaskan Native and/or b) from a medically underserved population (i.e. faced economic, cultural or linguistic barriers to health care)
Exclusion Criteria
- individuals ages 17 years or younger
- not registered as a CDU student
- unable to speak or understand English
- not considered to be underserved
For Aim 3:
Inclusion Criteria
- cancer survivor with a participating caregiver
- stage III or stage IV cancer diagnosis
- breast, lung, or colorectal cancer diagnosis
- identify as African American or Latinx
- speak and/or understand English
Exclusion Criteria
- individuals ages 17 years or younger
- does not identify as African American or Latinx
- unable to speak or understand English
- does not identify as a cancer survivor
- cancer survivor does not identify a caregiver
- does not have a breast, lung, or colorectal cancer diagnosis
- not diagnosed with a stage III or stage IV cancer diagnosis
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Survivorship Management among African American and Latinx Cancer Dyads
This arm will implement a "one group pre-test and posttest" design to improve health outcomes of African American and Latinx cancer survivors and caregivers in collaboration with health professional students trained as Cancer Survivorship and Caregiver Leaders Aimed for Minority Populations (CSC LAMPs).
|
Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Increase in psychosocial well-being using the Quality of Life: Short Form Health Survey and the Center for Epidemiologic Studies Depression Scale
Periodo de tiempo: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% increase in the psychosocial well-being among study participants.
|
3 months
|
|
Reduction of barriers to symptom management Using the Symptom Distress Scale survey
Periodo de tiempo: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% decrease in the barriers to symptom management among study participants.
|
3 months
|
|
3. Decrease in unmet needs Using the Barriers to Follow-Up Care Survey and Cancer Survivors Unmet Needs instrument
Periodo de tiempo: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% decrease in the unmet needs among study participants.
|
3 months
|
|
Reduction in caregiver burden using the Caregiver reaction assessment (CRA) survey
Periodo de tiempo: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% decrease in the caregiver burden among study participants.
|
3 months
|
|
5. Increase knowledge and utilization of supportive services using the Medical Outcomes Study Social Support Survey
Periodo de tiempo: 3 months
|
By comparison from baseline to post-intervention, there will be a 25% increase in the knowledge and utilization of supportive services among study participants.
|
3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sharon Cobb, Charles R. Drew University of Medicine & Science
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2021
Finalización primaria (Anticipado)
30 de junio de 2024
Finalización del estudio (Anticipado)
31 de diciembre de 2024
Fechas de registro del estudio
Enviado por primera vez
22 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
22 de diciembre de 2020
Publicado por primera vez (Actual)
28 de diciembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2022
Última verificación
1 de julio de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CancerDyads
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .