- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01696539
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. september 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
42
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Narke
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Orebro, Narke, Sverige, 701-82
- Örebro University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
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.
|
Aktiv komparator: 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.
|
Hva måler studien?
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
C-Reactive Protein
Tidsramme: 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
|
High-Density Lipoprotein
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Triglycerides
Tidsramme: 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
|
Insulin
Tidsramme: 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
|
Testosterone
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
At time of randomisation(March 1, 2010) and after 11 weeks
|
Self-Reported Sleep Quality
Tidsramme: 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
|
Self-Reported Emotional Quality of Life
Tidsramme: At time of randomisation(March 1, 2010) and after 11 weeks
|
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
|
Self-Reported Physical Quality of Life
Tidsramme: At time of randomisation(March 1, 2010) and after 11 weeks
|
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
|
Blodpressur, systolic and diastolic.
Tidsramme: At time of randomisation(March 1, 2010) and after 11 weeks
|
Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks
|
At time of randomisation(March 1, 2010) and after 11 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ove Andren, PhD, Örebro University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2010
Primær fullføring (Faktiske)
1. mai 2010
Studiet fullført (Faktiske)
1. mai 2010
Datoer for studieregistrering
Først innsendt
16. september 2012
Først innsendt som oppfylte QC-kriteriene
27. september 2012
Først lagt ut (Anslag)
1. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. oktober 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2012
Sist bekreftet
1. september 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Spartacus01
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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