Hacer que los hábitos saludables se mantengan (HABITS)
26 de septiembre de 2025 actualizado por: University of Tennessee
Cómo hacer que los hábitos saludables se mantengan: intervenciones de contacto extendido para promover la actividad física a largo plazo en sobrevivientes de cáncer afroamericanos
El objetivo de este proyecto es ayudar a aumentar el mantenimiento de la actividad física en los sobrevivientes de cáncer que tienen más probabilidades de experimentar disparidades de salud y desventajas sociales.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
El propósito del estudio es evaluar intervenciones novedosas diseñadas para ayudar a las mujeres sobrevivientes de cáncer, que se identifican como afroamericanas o negras, a superar las barreras del ejercicio, desarrollar una mentalidad físicamente activa y establecer hábitos de ejercicio necesarios para hacer ejercicio a largo plazo.
Estas novedosas intervenciones son 1.
Mensajes de texto (SMS), 2. Asesoramiento entre pares, 3. Combinación de asesoramiento entre pares y SMS, 4. Atención habitual
Tipo de estudio
Intervencionista
Inscripción (Estimado)
260
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.
Estudio Contacto
- Nombre: Michelle Martin, PhD
- Número de teléfono: 901-448-2383
- Correo electrónico: mmart126@uthsc.edu
Copia de seguridad de contactos de estudio
- Nombre: Talia Williams, BA
- Número de teléfono: 901-448-8682
- Correo electrónico: twill213@uthsc.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Reclutamiento
- University of Alabama at Birmingham
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Contacto:
- Laura Rogers, MD, MPH
- Número de teléfono: 205-934-9735
- Correo electrónico: lqrogers@uabmc.edu
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Contacto:
- Ildiko Nyikos, MA, ACSM-RCEP, EIM-3
- Número de teléfono: 205-975-0002
- Correo electrónico: inyikos@uabmc.edu
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Investigador principal:
- Laura Rogers, MD, MPH
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38163
- Reclutamiento
- University of Tennessee Health Science Center
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Contacto:
- Michelle Martin, PhD
- Número de teléfono: 901-448-2383
- Correo electrónico: mmart126@uthsc.edu
-
Contacto:
- Talia Williams, BA
- Número de teléfono: 901-448-8682
- Correo electrónico: twill213@uthsc.edu
-
Investigador principal:
- Michelle Martin,, PhD
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- mujer de 19 años o más
- se identifica como afroamericano o negro
- tiene antecedentes de cáncer
- haber completado el tratamiento posprimario para el cáncer (es decir, quimioterapia, radiación)
- acepta permitir que el equipo de investigación confirme el diagnóstico de cáncer con su médico
- Si se sometió a cirugía, debe haber transcurrido al menos 8 semanas después de la cirugía.
- dispuesto a que un médico habitual proporcione autorización médica para participar en el estudio
- dispuesto a proporcionar la dirección de su casa si califica para el estudio
- dispuesto y capaz de utilizar una plataforma de videoconferencia como Zoom para actividades de estudio (debe estar dispuesto y capaz)
- dispuesto y capaz de enviar y/o recibir mensajes de texto (debe estar dispuesto y capaz)
- tiene número de teléfono de EE.UU.
- tiene una dirección de correo electrónico
- Si no tiene dirección de correo electrónico, debe estar dispuesto a crear una.
- Habla ingles
- Capaz de deambular sin ayuda (no necesita usar un bastón, un andador o una silla de ruedas)
- dispuesto y capaz de completar de 3 a 5 sesiones de ejercicio por semana por su cuenta durante la duración del estudio; si la respuesta es no, explique
- dispuesto a asistir a sesiones individuales y grupales a través de videoconferencias durante la participación en el estudio; Si la respuesta es negativa, explique.
- dispuesto a asistir a evaluaciones mediante videoconferencia durante la participación en el estudio; Si la respuesta es negativa, explique.
- dispuesto a completar encuestas durante la participación en el estudio; Si la respuesta es negativa, explique.
Criterios de exclusión:
- Cáncer metastásico o recurrente.
- otro diagnóstico de cáncer en los últimos 5 años (sin incluir el cáncer de piel o de cuello uterino in situ)
- Tiene problemas ortopédicos, articulares o cualquier otra afección grave que impida que el individuo esté activo.
- angina inestable
- tiene pintura, opresión o pesadez en el pecho YA SEA cuando está descansando O cuando hace actividad física
- tiene insuficiencia cardíaca congestiva de clase II, III o IV de la New York Heart Association
- la presión arterial ha estado por encima de 160/100 al menos dos veces en los últimos 6 meses (cualquier número; 160 o 100)
- tiene asma no controlada
- tiene enfermedad pulmonar intersticial que requiere oxígeno adicional
- tiene demencia u organiza el síndrome cerebral
- tiene esquizofrenia o psicosis activa
- ha tenido un derrame cerebral u otro problema que dejó al individuo discapacitado o con parálisis (incapaz de moverse o sentir alguna parte del cuerpo)
- tiene problemas de audición que dificultan mantener una conversación telefónica
- ciego o parcialmente ciego
- cirugía planificada durante los primeros 6 meses de participación en el estudio (si no está aprobada por IP)
- Cirugía planificada de rodilla o cadera durante los primeros 6 meses de participación en el estudio.
- anticipar cambios en los medicamentos habituales durante los primeros 6 meses de participación en el estudio (si no están aprobados por IP)
- un médico le ha dicho que solo haga ejercicio prescrito por un médico
- Un médico le ha indicado que limite la actividad física.
- Tiene una contraindicación para realizar ejercicio aeróbico de intensidad moderada.
- haber completado en promedio más de 90 min/semana de ejercicio de intensidad moderada o más de 30 min/semana de ejercicio vigoroso en los últimos 6 meses
- problemas con el equilibrio o moverse con seguridad
- está actualmente embarazada o prevé estar embarazada durante la participación en el estudio
- actualmente participando en otro estudio de ejercicio
- tener IMC ≥ 50
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: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Entrenador de pares y SMS
Intervenciones de SMS y entrenadores de pares centradas en el mantenimiento de la actividad física
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La intervención del Sistema de mensajes cortos (SMS) se centra en mensajes SMS personalizados y adaptativos que ayudan al participante a mantener conductas de actividad física.
El entrenador de pares realizará una intervención que ayudará a los participantes a mantener la actividad física.
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Experimental: Entrenador de pares
Intervención de un entrenador de pares centrada en el mantenimiento de la actividad física
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El entrenador de pares realizará una intervención que ayudará a los participantes a mantener la actividad física.
Otros nombres:
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Experimental: Servicio de mensajes cortos (SMS)
Intervención por SMS centrada en el mantenimiento de la actividad física
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La intervención del Sistema de mensajes cortos (SMS) se centra en mensajes SMS personalizados y adaptativos que ayudan al participante a mantener conductas de actividad física.
Otros nombres:
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Otro: Cuidado habitual
Materiales escritos enfocados al mantenimiento de la actividad física.
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Los participantes recibirán materiales escritos que brindarán consejos sobre cómo mantener su actividad física.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Actividad física (resultado informado por el paciente)
Periodo de tiempo: Desde el inicio hasta la evaluación de 15 meses
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Los participantes llevarán un sensor de movimiento en la cintura durante 7 días.
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Desde el inicio hasta la evaluación de 15 meses
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fatiga (resultado informado por el paciente)
Periodo de tiempo: Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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La fatiga se medirá utilizando la escala del Inventario de síntomas de fatiga (intensidad e interferencia de la fatiga).
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Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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Salud autopercibida (resultado informado por el paciente)
Periodo de tiempo: Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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La salud autopercibida se medirá mediante el cuestionario EQ-5D.
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Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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Calificación de vida (resultado informado por el paciente)
Periodo de tiempo: Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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La calidad de vida se medirá mediante el cuestionario PROMIS Global Health.
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Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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Ansiedad y depresión (resultado informado por el paciente)
Periodo de tiempo: Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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La ansiedad y la depresión se medirán mediante la Escala hospitalaria de ansiedad y depresión.
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Al inicio, evaluación a los 3 meses, evaluación a los 9 meses y evaluación a los 15 meses.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estrés (resultado informado por el paciente)
Periodo de tiempo: Al inicio, 3 meses, 9 meses y 15 meses
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El estrés se medirá utilizando la Escala de Estrés Percibido.
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Al inicio, 3 meses, 9 meses y 15 meses
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Determinantes sociales de la salud
Periodo de tiempo: Al inicio, 3 meses, 9 meses, 15 meses
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Los determinantes sociales de la salud se medirán mediante el cuestionario de Determinantes Sociales de la Salud (SDoH).
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Al inicio, 3 meses, 9 meses, 15 meses
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Personalidad de los Cinco Grandes (resultado informado por el paciente)
Periodo de tiempo: Al inicio, 3 meses, 9 meses, 15 meses
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La personalidad de los cinco grandes se medirá utilizando una versión breve del cuestionario del Inventario de personalidad de los cinco grandes.
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Al inicio, 3 meses, 9 meses, 15 meses
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Autoinforme de actividad física
Periodo de tiempo: Al inicio, 3 meses, 9 meses, 15 meses
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El ejercicio aeróbico y de resistencia se medirá mediante el cuestionario Godin de fuerza aeróbica.
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Al inicio, 3 meses, 9 meses, 15 meses
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Calidad de vida (resultado informado por el paciente)
Periodo de tiempo: Al inicio, 3 meses, 9 meses, 15 meses
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La calidad de vida se medirá mediante el cuestionario EQ-5D-5L.
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Al inicio, 3 meses, 9 meses, 15 meses
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Apoyo social para la actividad física (resultado informado por el paciente)
Periodo de tiempo: Al inicio, 3 meses, 9 meses, 15 meses
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El apoyo social a la actividad física se medirá mediante el cuestionario de Apoyo Social para la AF.
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Al inicio, 3 meses, 9 meses, 15 meses
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Procesos reflexivos, regulatorios y reflexivos (resultado informado por el paciente)
Periodo de tiempo: Línea de base, 3 meses, 6 meses, 9 meses, 12 meses, 15 meses
|
Los procesos reflexivos, regulatorios y reflexivos se miden mediante el cuestionario de actividad física M-PAC.
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Línea de base, 3 meses, 6 meses, 9 meses, 12 meses, 15 meses
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Interferencia de barreras de ejercicio percibidas
Periodo de tiempo: Al inicio, 3 meses, 9 meses, 15 meses
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Las barreras para el ejercicio se medirán mediante el cuestionario de barreras percibidas para el ejercicio.
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Al inicio, 3 meses, 9 meses, 15 meses
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle Martin, PhD, University of Tennessee
- Investigador principal: Laura Rogers, MD, MPH, University of Alabama at Birmingham
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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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)
27 de enero de 2025
Finalización primaria (Estimado)
31 de marzo de 2028
Finalización del estudio (Estimado)
31 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de diciembre de 2024
Primero enviado que cumplió con los criterios de control de calidad
17 de diciembre de 2024
Publicado por primera vez (Actual)
20 de diciembre de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Estimado)
1 de octubre de 2025
Última actualización enviada que cumplió con los criterios de control de calidad
26 de septiembre de 2025
Última verificación
1 de septiembre de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-300011855
- R01MD018375 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Las personas interesadas en solicitar IPD deben comunicarse con los IP del estudio.
Marco de tiempo para compartir IPD
Una vez finalizada la gestión de datos (y bloqueados los datos) y enviado el manuscrito que informa los datos de mantenimiento de la actividad física en el mes 15.
Criterios de acceso compartido de IPD
Se requerirá un acuerdo de uso de datos entre la institución que alberga los datos (UTHSC) y la institución del investigador solicitante.
Tipo de información de apoyo para compartir IPD
- CIF
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. .