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
2012년 9월 27일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
42
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Narke
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Orebro, Narke, 스웨덴, 701-82
- Örebro University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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C-Reactive Protein
기간: 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
기간: 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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Adiponectin
기간: 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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Total Cholesterol
기간: 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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Triglycerides
기간: 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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Insulin
기간: 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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Testosterone
기간: 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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Estradiol
기간: 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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Self-Reported Stress
기간: At time of randomisation(March 1, 2010) and after 11 weeks
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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
기간: 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
기간: 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
기간: 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.
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ove Andren, PhD, Örebro University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 3월 1일
기본 완료 (실제)
2010년 5월 1일
연구 완료 (실제)
2010년 5월 1일
연구 등록 날짜
최초 제출
2012년 9월 16일
QC 기준을 충족하는 최초 제출
2012년 9월 27일
처음 게시됨 (추정)
2012년 10월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 10월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 9월 27일
마지막으로 확인됨
2012년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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