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A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

7 de mayo de 2019 actualizado por: Case Comprehensive Cancer Center

A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.

Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.

The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.

Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.

Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.

Tipo de estudio

Intervencionista

Inscripción (Actual)

17

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

  • Estados Unidos
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  1. Women at high risk of breast cancer due to one or more of the following:

    • Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
    • Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
    • Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
  2. Ability to access the internet and watch videos online.
  3. Valid email address.
  4. Self-reported sleep duration of 6 hours per night or less

Exclusion Criteria:

  1. Previous diagnosis of cancer.
  2. Lack of ability to read and converse in English.
  3. Lack of ability to give informed consent.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: GO! To Sleep
Participants in the intervention group will be provided with a code and website address to participate in this program. This program includes reminder emails and is 6 weeks in duration. Participants will be given a blood draw to measure biomarkers.
Conductual: GO! To Sleep
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Procedimiento: Blood Draw
blood sample measured for stress and sleep markers
Otros nombres:
  • biomarker measurement
Otro: Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Otro: Insomnia Severity Index (ISI)
Otro: SF-12 quality of life survey
Comparador activo: informational control
Participants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers.
Procedimiento: Blood Draw
blood sample measured for stress and sleep markers
Otros nombres:
  • biomarker measurement
Otro: Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Otro: Insomnia Severity Index (ISI)
Otro: SF-12 quality of life survey
Conductual: Sleep information
Participants will receive weekly emails on the health benefits of sleep for 6 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Periodo de tiempo: Change from baseline to post intervention, around 8 weeks after baseline
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in Insomnia Severity Index (ISI) score between groups
Periodo de tiempo: Change from baseline to post intervention, around 8 weeks after baseline
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in sleep duration between groups
Periodo de tiempo: Change from baseline to post intervention, around 8 weeks after baseline
Sleep duration will be obtained by self-report from responses to the PSQI
Change from baseline to post intervention, around 8 weeks after baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in change of SF-12 score from baseline to post-intervention between groups
Periodo de tiempo: Change from baseline to 6 months post intervention
The effectiveness of changing health-related quality of life after the GO! To Sleep program will he measured with the self-reported survey SF-12
Change from baseline to 6 months post intervention
Correlation of joint changes in biomarker levels with PSQI and ISI
Periodo de tiempo: Change from baseline to 6 months post intervention
This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Change from baseline to 6 months post intervention
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Periodo de tiempo: Change from baseline to 6 months post intervention
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Change from baseline to 6 months post intervention
Difference in change in Insomnia Severity Index (ISI) score between groups
Periodo de tiempo: Change from baseline to 6 months post intervention
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Change from baseline to 6 months post intervention
Difference in change in sleep duration between groups
Periodo de tiempo: Change from baseline to 6 months post intervention
Sleep duration will be obtained by self-report from responses to the PSQI
Change from baseline to 6 months post intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Case Comprehensive Cancer Center

Investigadores

  • Investigador principal: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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 (Actual)

4 de agosto de 2015

Finalización primaria (Actual)

23 de marzo de 2017

Finalización del estudio (Actual)

23 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

23 de noviembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

23 de noviembre de 2015

Publicado por primera vez (Estimar)

25 de noviembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

7 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CASE6114

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. .

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