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 septembre 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
42
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Narke
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Orebro, Narke, Suède, 701-82
- Örebro university
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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C-Reactive Protein
Délai: 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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High-Density Lipoprotein
Délai: 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
|
|
Adiponectin
Délai: 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
Délai: 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
Délai: 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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Insulin
Délai: 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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Testosterone
Délai: 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
|
|
Estradiol
Délai: 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
Délai: At time of randomisation(March 1, 2010) and after 11 weeks
|
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
Délai: At time of randomisation(March 1, 2010) and after 11 weeks
|
Self-reported sleep quality measured using the Karolinska Sleepiness Scale.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
|
At time of randomisation(March 1, 2010) and after 11 weeks
|
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Self-Reported Emotional Quality of Life
Délai: 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.
|
At time of randomisation(March 1, 2010) and after 11 weeks
|
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Self-Reported Physical Quality of Life
Délai: 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.
|
At time of randomisation(March 1, 2010) and after 11 weeks
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Blodpressur, systolic and diastolic.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ove Andren, PhD, Örebro university
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2010
Achèvement primaire (Réel)
1 mai 2010
Achèvement de l'étude (Réel)
1 mai 2010
Dates d'inscription aux études
Première soumission
16 septembre 2012
Première soumission répondant aux critères de contrôle qualité
27 septembre 2012
Première publication (Estimation)
1 octobre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 octobre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 septembre 2012
Dernière vérification
1 septembre 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Spartacus01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .