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
2012年9月27日 更新者：Ove Andrén、Örebro University, Sweden
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
42
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Narke
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Orebro、Narke、スウェーデン、701-82
- Örebro University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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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アクティブコンパレータ：Standard of Care
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
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Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
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この研究は何を測定していますか？
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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C-Reactive Protein
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
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Levels assessed in blood.
Blood draw performed by clinician at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
|
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High-Density Lipoprotein
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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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Total Cholesterol
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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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Triglycerides
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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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Insulin
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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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Testosterone
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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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Estradiol
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
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
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
|
Self-reported stress level measured using the Perceived Stress Scale-4.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
|
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Self-Reported Sleep Quality
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
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Self-reported sleep quality measured using the Karolinska Sleepiness Scale.
Questionnaire completed by participant at start and 11 weeks after start of intervention.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Self-Reported Emotional Quality of Life
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
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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.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Self-Reported Physical Quality of Life
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
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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.
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At time of randomisation(March 1, 2010) and after 11 weeks
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Blodpressur, systolic and diastolic.
時間枠：At time of randomisation(March 1, 2010) and after 11 weeks
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Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks
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At time of randomisation(March 1, 2010) and after 11 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ove Andren, PhD、Örebro University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年3月1日
一次修了 (実際)
2010年5月1日
研究の完了 (実際)
2010年5月1日
試験登録日
最初に提出
2012年9月16日
QC基準を満たした最初の提出物
2012年9月27日
最初の投稿 (見積もり)
2012年10月1日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年10月1日
QC基準を満たした最後の更新が送信されました
2012年9月27日
最終確認日
2012年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。