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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 september 2012 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

42

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
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.
Övrig: Standard of Care
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Vad mäter studien?

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
C-Reactive Protein
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Örebro University, Sweden

Samarbetspartners

Harvard School of Public Health (HSPH)

Utredare

  • Huvudutredare: Ove Andren, PhD, Örebro University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2010

Primärt slutförande (Faktisk)

1 maj 2010

Avslutad studie (Faktisk)

1 maj 2010

Studieregistreringsdatum

Först inskickad

16 september 2012

Först inskickad som uppfyllde QC-kriterierna

27 september 2012

Första postat (Uppskatta)

1 oktober 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

1 oktober 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 september 2012

Senast verifierad

1 september 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Spartacus01

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