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

This study has been completed.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Ove Andrén, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01696539
First received: September 16, 2012
Last updated: September 27, 2012
Last verified: September 2012

September 16, 2012
September 27, 2012
March 2010
May 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01696539 on ClinicalTrials.gov Archive Site
  • C-Reactive Protein [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • High-Density Lipoprotein [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Adiponectin [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Total Cholesterol [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Triglycerides [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Insulin [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Testosterone [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Estradiol [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
  • Self-Reported Stress [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Self-reported stress level measured using the Perceived Stress Scale-4. Questionnaire completed by participant at start and 11 weeks after start of intervention.
  • Self-Reported Sleep Quality [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Self-reported sleep quality measured using the Karolinska Sleepiness Scale. Questionnaire completed by participant at start and 11 weeks after start of intervention.
  • Self-Reported Emotional Quality of Life [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    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.
  • Self-Reported Physical Quality of Life [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    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.
  • Blodpressur, systolic and diastolic. [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
    Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Prostatic Neoplasm
  • Behavioral: 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.
  • Other: Standard of Care
    Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
  • 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.
    Intervention: Behavioral: Walking Intervention
  • Active Comparator: Standard of Care
    Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
    Intervention: Other: Standard of Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Male
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01696539
Spartacus01
Yes
Ove Andrén, Örebro University, Sweden
Örebro University, Sweden
Harvard School of Public Health
Principal Investigator: Ove Andren, PhD Orebro University
Örebro University, Sweden
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP