Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
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Alberta
-
Calgary, Alberta, Canadá
- Reclutamiento
- Tom Baker Cancer Centre
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Grande Prairie, Alberta, Canadá
- Reclutamiento
- Grande Prairie Cancer Centre
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Lethbridge, Alberta, Canadá
- Reclutamiento
- Lethbridge Cancer Centre
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Medicine Hat, Alberta, Canadá
- Reclutamiento
- Medicine Hat Cancer Centre
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Red Deer, Alberta, Canadá
- Reclutamiento
- Central Alberta Cancer Centre
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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:
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
- do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PA Behavior Intervention
Physical Activity Resource Kit
|
The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration). |
|
Comparador activo: Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
|
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Self-reported physical activity
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cancer specific health related quality of life
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Psychosocial health outcomes
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Objective step counts (pedometer)
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Chemotherapy completion rate
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Determinants of physical activity
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Physical functioning
Periodo de tiempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeff Vallance, PhD, Athabasca University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- PROACTIVE
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