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

Prostatic Neoplasm Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696539
• Other study ID #: Spartacus01
• Status: Completed
• Phase: N/A
• First received: September 16, 2012
• Last updated: September 27, 2012
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Orebro University	Orebro	Narke

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Harvard School of Public Health

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View Citation

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):801-7. doi: 10.1093/annonc/mdq443. Epub 2010 Sep 29. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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