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

NCT01696539 | Completed DMC

• 1 other identifier: Spartacus01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Keywords

Prostate Cancer

Outcome Measures

Secondary Outcomes (13)

• C-Reactive Protein

  At time of randomisation(March 1, 2010) and after 11 weeks

• High-Density Lipoprotein

  At time of randomisation(March 1, 2010) and after 11 weeks

• Adiponectin

  At time of randomisation(March 1, 2010) and after 11 weeks

• Total Cholesterol

  At time of randomisation(March 1, 2010) and after 11 weeks

• Triglycerides

  At time of randomisation(March 1, 2010) and after 11 weeks

Study Arms (2)

Walking Intervention

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Other: Standard of Care

Interventions

Walking Intervention BEHAVIORAL

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.

Walking Intervention

Standard of Care OTHER

Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Standard of Care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Orebro University

Örebro, Narke, 701-82, Sweden

Location

Related Publications (9)

• 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.

  PMID: 21205749 BACKGROUND

• 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.

  PMID: 20880998 BACKGROUND

• 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.

  PMID: 18202010 BACKGROUND

• 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.

  PMID: 12928350 BACKGROUND

• 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.

  PMID: 17179483 BACKGROUND

• 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.

  PMID: 19910504 BACKGROUND

• 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.

  PMID: 21115859 BACKGROUND

• 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.

  PMID: 21640547 BACKGROUND

• 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.

  PMID: 21798015 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ove Andren, PhD

  OREBRO UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair of Urology

Study Record Dates

• First Submitted: September 16, 2012
• First Posted: October 1, 2012
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

SE (1)