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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ove Andren, PhD | OREBRO UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orebro University | Örebro | Narke | 701-82 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21205749 | Background | 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. | |
| 20880998 | 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. |
| Label | URL |
|---|---|
| Orebro University English Homepage | View source |
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|
| Standard of Care | Other | Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention. |
|
| 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 |
| 18202010 | 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. |
| 12928350 | 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. |
| 17179483 | 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. |
| 19910504 | 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. |
| 21115859 | 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. |
| 21640547 | 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. |
| 21798015 | 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. |
| Harvard School of Public Health Homepage | View source |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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