Clinical trial NCT01696539: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Keywords: Prostate Cancer
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2012-10-01
Enrollment: 42
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
measure: C-Reactive Protein
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: High-Density Lipoprotein
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Adiponectin
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Total Cholesterol
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Triglycerides
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Insulin
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Testosterone
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Estradiol
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Self-Reported Stress
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Self-Reported Sleep Quality
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Self-Reported Emotional Quality of Life
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Self-Reported Physical Quality of Life
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
measure: Blodpressur, systolic and diastolic.
timeFrame: At time of randomisation(March 1, 2010) and after 11 weeks
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Orebro University
state: Narke
Study officials:
affiliation: OREBRO UNIVERSITY
name: Ove Andren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kenfield SA, Stampfer MJ, Giovannucci E, Chan JM. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. 2011 Feb 20;29(6):726-32. doi: 10.1200/JCO.2010.31.5226. Epub 2011 Jan 4.
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citation: Giovannucci E, Rimm EB, Liu Y, Leitzmann M, Wu K, Stampfer MJ, Willett WC. Body mass index and risk of prostate cancer in U.S. health professionals. J Natl Cancer Inst. 2003 Aug 20;95(16):1240-4. doi: 10.1093/jnci/djg009.
citation: Platz EA, Leitzmann MF, Visvanathan K, Rimm EB, Stampfer MJ, Willett WC, Giovannucci E. Statin drugs and risk of advanced prostate cancer. J Natl Cancer Inst. 2006 Dec 20;98(24):1819-25. doi: 10.1093/jnci/djj499.
citation: Li H, Stampfer MJ, Mucci L, Rifai N, Qiu W, Kurth T, Ma J. A 25-year prospective study of plasma adiponectin and leptin concentrations and prostate cancer risk and survival. Clin Chem. 2010 Jan;56(1):34-43. doi: 10.1373/clinchem.2009.133272. Epub 2009 Nov 12.
citation: Irwin ML, Duggan C, Wang CY, Smith AW, McTiernan A, Baumgartner RN, Baumgartner KB, Bernstein L, Ballard-Barbash R. Fasting C-peptide levels and death resulting from all causes and breast cancer: the health, eating, activity, and lifestyle study. J Clin Oncol. 2011 Jan 1;29(1):47-53. doi: 10.1200/JCO.2010.28.4752. Epub 2010 Nov 29.
citation: Keogh JW, MacLeod RD. Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. J Pain Symptom Manage. 2012 Jan;43(1):96-110. doi: 10.1016/j.jpainsymman.2011.03.006. Epub 2011 Jun 2.
citation: Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, Hatano Y, Inoue S, Matsudo SM, Mutrie N, Oppert JM, Rowe DA, Schmidt MD, Schofield GM, Spence JC, Teixeira PJ, Tully MA, Blair SN. How many steps/day are enough? For adults. Int J Behav Nutr Phys Act. 2011 Jul 28;8:79. doi: 10.1186/1479-5868-8-79.