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Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight

21 de febrero de 2017 actualizado por: Duke University

RENEW: Reach Out to Enhance Wellness in Older Survivors

RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

Descripción general del estudio

Descripción detallada

OBJECTIVES:

Primary

  • Compare the physical function over 1 year of overweight older long-term cancer survivors assigned to immediate vs delayed exercise and dietary counseling.

Secondary

  • Compare physical activity, saturated fat and vegetable and fruit intake, body mass index, depression, and general health and well being of experimental arm patients vs control arm patients.
  • Evaluate self-efficacy, social support, comorbidity, cancer-type, and gender as factors associated with program efficacy.
  • Determine the functional decline over a 2-year period in patients who undergo immediate vs delayed intervention.
  • Characterize the mathematical form, over a 2-year period, of physical functioning trajectories among older cancer survivors, including determining if the intervention effects are durable in those who receive the intervention initially and whether "catch-up" is possible in the delayed intervention arm.

OUTLINE: This is a randomized study. Patients are stratified according to cancer type (colorectal vs breast or prostate), sex, age (65-74 years vs 75 years and over), and race (white vs non-white). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (immediate intervention): Patients receive a personalized notebook of diet and exercise information, exercise equipment, and logbooks to record food intake and exercise behaviors. Patients undergo 20-minute telephone discussions with a health counselor once weekly for 3 weeks, every 2 weeks for 2 months, and then monthly for up to 1 year for a total of 15 sessions. Patients also undergo a 5-minute telephone survey to assess health every 3 months.
  • Arm II (delayed intervention): Patients undergo intervention as in arm I after a 1-year waiting period.

After completion of study intervention, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

641

Fase

  • Fase 2

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

    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke 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

65 años a 120 años (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Diagnosed colorectal, prostate, or female breast cancer

    • At least 5 years beyond date of diagnosis with no clinical evidence of progressive disease or second primaries
  • Body mass index ≥ 25 kg/m^2 and < 40 kg/m^2
  • Currently exercising < 150 minutes/week
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:

    • Severe orthopedic condition or scheduled hip or knee replacement within the next 6 months
    • Paralysis
    • End-stage renal disease
    • Dementia
    • Unstable angina
    • Heart attack, congestive heart failure, or pulmonary condition that required oxygen or hospitalization within the past 6 months
  • Ability to read, write, and speak English

PRIOR CONCURRENT THERAPY:

  • No concurrent warfarin

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Wait-list control
Wait-list control received diet & exercise counseling during year 2 as a courtesy
Experimental: Lifestyle counseling
subjects randomized to receive diet & exercise counseling for one year

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Stage of readiness for exercise and dietary change as assessed by the stage of change algorithms at baseline and years 1 and 2 following study completion
Periodo de tiempo: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Silla de estudio: Wendy Demark-Wahnefried, PhD, Duke Cancer Institute

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

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

1 de diciembre de 2003

Finalización primaria (Actual)

1 de junio de 2008

Finalización del estudio (Actual)

1 de mayo de 2009

Fechas de registro del estudio

Enviado por primera vez

15 de marzo de 2006

Primero enviado que cumplió con los criterios de control de calidad

15 de marzo de 2006

Publicado por primera vez (Estimar)

17 de marzo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de febrero de 2017

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

21 de febrero de 2017

Última verificación

1 de febrero de 2013

Más información

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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