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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Prostatic Neoplasm

Intervention / Treatment
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* Behavioral: Walking Intervention
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Intervention<br>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. | Behavioral: Walking Intervention<br>* 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.<br>|
| Active Comparator: Standard of Care<br>Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention. | Other: Standard of Care<br>* Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer