Steps for PRosTAte Cancer Health and Survival (SPaRTACuS): Pilot Study of a Walking Intervention to Improve Health and Quality of Life in Prostate Cancer Patients
27 de septiembre de 2012 actualizado por: Ove Andrén, Örebro University, Sweden
Pilot Intervention Study of the Impact of Sustainable Daily Physical Activity on Health and Quality of Life in a Cohort of Men With Prostate Cancer in Sweden: Steps for PRosTAte Cancer Health and Survival (SPaRTACuS)
The purpose of this study is to determine whether sustainable daily physical activity is effective in improving biological indicators of health and self-reported quality of life in men with prostate cancer.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Living with prostate cancer is a unique challenge faced by millions of men across the globe.
Existing research has indicated many potential methods of attenuating prostate cancer progression and preserving patients' quality of life, but is lacking in definitive conclusions regarding the effectiveness of these methods in practice.
This study seeks to further investigate the impact of post-diagnosis physical activity on biological indicators of health and self-reported quality of life in a cohort of men with prostate cancer in Sweden.
Participants are randomized to either a walking intervention group, which encourages walking 10,000 steps per day for one year, or to a standard-or-care control group, and followed for 11 weeks.
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
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
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-
Narke
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Orebro, Narke, Suecia, 701-82
- Örebro University
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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
40 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Age 80 years or younger
- Histologic confirmation of prostate cancer
- Clinically or pathologically staged as locally advanced or early metastatic prostate cancer
- Diagnosis within 1 year of study enrollment
- Willing and able to walk 10,000 steps per day
Exclusion Criteria:
- Age greater than 80 years old at enrollment
- Inability to understand the language spoken in host country
- Physically unable to walk 100 meters unassisted
- Diagnosed with dementia or severe psychiatric disease
- Any prior cancer diagnosis
- Has experienced a myocardial infarction or stroke within six months of 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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Walking Intervention
Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention.
Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse.
Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day.
This journal is submitted to investigators at the end of the intervention period.
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Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention.
Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse.
Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day.
This journal is submitted to investigators at the end of the intervention period.
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Comparador activo: Standard of Care
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
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Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
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¿Qué mide el estudio?
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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C-Reactive Protein
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
|
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High-Density Lipoprotein
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
|
At time of randomisation(March 1, 2010) and after 11 weeks
|
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Adiponectin
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
|
At time of randomisation(March 1, 2010) and after 11 weeks
|
|
Total Cholesterol
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
|
At time of randomisation(March 1, 2010) and after 11 weeks
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Triglycerides
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
|
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Insulin
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
|
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Testosterone
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
|
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Estradiol
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
|
Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
|
At time of randomisation(March 1, 2010) and after 11 weeks
|
|
Self-Reported Stress
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
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Self-reported stress level measured using the Perceived Stress Scale-4.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Self-Reported Sleep Quality
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
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Self-reported sleep quality measured using the Karolinska Sleepiness Scale.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Self-Reported Emotional Quality of Life
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
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Self-reported emotional quality of life using the 21-Item Depression Anxiety Stress Scale, DASS-21.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Self-Reported Physical Quality of Life
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
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Self-reported physical quality of life measures related to urinary, bowel, and sexual function using the FACT-P questionnaire.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Blodpressur, systolic and diastolic.
Periodo de tiempo: At time of randomisation(March 1, 2010) and after 11 weeks
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Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks
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At time of randomisation(March 1, 2010) and after 11 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ove Andren, PhD, Örebro University
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
- Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, Hatano Y, Inoue S, Matsudo SM, Mutrie N, Oppert JM, Rowe DA, Schmidt MD, Schofield GM, Spence JC, Teixeira PJ, Tully MA, Blair SN. How many steps/day are enough? For adults. Int J Behav Nutr Phys Act. 2011 Jul 28;8:79. doi: 10.1186/1479-5868-8-79.
- Kenfield SA, Stampfer MJ, Giovannucci E, Chan JM. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. 2011 Feb 20;29(6):726-32. doi: 10.1200/JCO.2010.31.5226. Epub 2011 Jan 4.
- Flanagan J, Gray PK, Hahn N, Hayes J, Myers LJ, Carney-Doebbeling C, Sweeney CJ. Presence of the metabolic syndrome is associated with shorter time to castration-resistant prostate cancer. Ann Oncol. 2011 Apr;22(4):801-807. doi: 10.1093/annonc/mdq443. Epub 2010 Sep 29.
- Edwards LA, Woo J, Huxham LA, Verreault M, Dragowska WH, Chiu G, Rajput A, Kyle AH, Kalra J, Yapp D, Yan H, Minchinton AI, Huntsman D, Daynard T, Waterhouse DN, Thiessen B, Dedhar S, Bally MB. Suppression of VEGF secretion and changes in glioblastoma multiforme microenvironment by inhibition of integrin-linked kinase (ILK). Mol Cancer Ther. 2008 Jan;7(1):59-70. doi: 10.1158/1535-7163.MCT-07-0329.
- Giovannucci E, Rimm EB, Liu Y, Leitzmann M, Wu K, Stampfer MJ, Willett WC. Body mass index and risk of prostate cancer in U.S. health professionals. J Natl Cancer Inst. 2003 Aug 20;95(16):1240-4. doi: 10.1093/jnci/djg009.
- Platz EA, Leitzmann MF, Visvanathan K, Rimm EB, Stampfer MJ, Willett WC, Giovannucci E. Statin drugs and risk of advanced prostate cancer. J Natl Cancer Inst. 2006 Dec 20;98(24):1819-25. doi: 10.1093/jnci/djj499.
- Li H, Stampfer MJ, Mucci L, Rifai N, Qiu W, Kurth T, Ma J. A 25-year prospective study of plasma adiponectin and leptin concentrations and prostate cancer risk and survival. Clin Chem. 2010 Jan;56(1):34-43. doi: 10.1373/clinchem.2009.133272. Epub 2009 Nov 12.
- Irwin ML, Duggan C, Wang CY, Smith AW, McTiernan A, Baumgartner RN, Baumgartner KB, Bernstein L, Ballard-Barbash R. Fasting C-peptide levels and death resulting from all causes and breast cancer: the health, eating, activity, and lifestyle study. J Clin Oncol. 2011 Jan 1;29(1):47-53. doi: 10.1200/JCO.2010.28.4752. Epub 2010 Nov 29.
- Keogh JW, MacLeod RD. Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. J Pain Symptom Manage. 2012 Jan;43(1):96-110. doi: 10.1016/j.jpainsymman.2011.03.006. Epub 2011 Jun 2.
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 marzo de 2010
Finalización primaria (Actual)
1 de mayo de 2010
Finalización del estudio (Actual)
1 de mayo de 2010
Fechas de registro del estudio
Enviado por primera vez
16 de septiembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
27 de septiembre de 2012
Publicado por primera vez (Estimar)
1 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de octubre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
27 de septiembre de 2012
Última verificación
1 de septiembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Spartacus01
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
producto fabricado y exportado desde los EE. UU.
No
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