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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Behavioral: Walking Intervention; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: Standard of Care; Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Ove Andren, PhD, Örebro University

Publications and helpful links

General Publications

• 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.
• 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.
• Flanagan J, Gray PK, Hahn N, Hayes J, Myers LJ, Carney-Doebbeling C, Sweeney CJ. Presence of the metabolic syndrome is associated with shorter time to castration-resistant prostate cancer. Ann Oncol. 2011 Apr;22(4):801-807. doi: 10.1093/annonc/mdq443. Epub 2010 Sep 29.
• Edwards LA, Woo J, Huxham LA, Verreault M, Dragowska WH, Chiu G, Rajput A, Kyle AH, Kalra J, Yapp D, Yan H, Minchinton AI, Huntsman D, Daynard T, Waterhouse DN, Thiessen B, Dedhar S, Bally MB. Suppression of VEGF secretion and changes in glioblastoma multiforme microenvironment by inhibition of integrin-linked kinase (ILK). Mol Cancer Ther. 2008 Jan;7(1):59-70. doi: 10.1158/1535-7163.MCT-07-0329.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Orebro University English Homepage
• Harvard School of Public Health Homepage

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 16, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Spartacus01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No