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

• 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

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.

• 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

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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