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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 settembre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svezia
    • Narke
      • Orebro, Narke, Svezia, 701-82
        • Örebro University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: Standard of Care
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
Altro: Standard of Care
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Cosa sta misurando lo studio?

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
C-Reactive Protein
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Örebro University, Sweden

Collaboratori

Harvard School of Public Health (HSPH)

Investigatori

  • Investigatore principale: Ove Andren, PhD, Örebro University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2010

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 maggio 2010

Date di iscrizione allo studio

Primo inviato

16 settembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

27 settembre 2012

Primo Inserito (Stima)

1 ottobre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 ottobre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 settembre 2012

Ultimo verificato

1 settembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Spartacus01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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