search
Back to results

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

Primary Purpose

Prostatic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Walking Intervention
Standard of Care
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatic Neoplasm focused on measuring Prostate Cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Orebro University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walking Intervention

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

C-Reactive Protein
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
High-Density Lipoprotein
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Adiponectin
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Total Cholesterol
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Triglycerides
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Insulin
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Testosterone
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Estradiol
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
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.
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.
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.
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.
Blodpressur, systolic and diastolic.
Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks

Full Information

First Posted
September 16, 2012
Last Updated
September 27, 2012
Sponsor
Örebro University, Sweden
Collaborators
Harvard School of Public Health (HSPH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01696539
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
Collaborators
Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
Intervention Type
Behavioral
Intervention Name(s)
Walking Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
Secondary Outcome Measure Information:
Title
C-Reactive Protein
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
High-Density Lipoprotein
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Adiponectin
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Total Cholesterol
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Triglycerides
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Insulin
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Testosterone
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Estradiol
Description
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Self-Reported Stress
Description
Self-reported stress level measured using the Perceived Stress Scale-4. Questionnaire completed by participant at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Self-Reported Sleep Quality
Description
Self-reported sleep quality measured using the Karolinska Sleepiness Scale. Questionnaire completed by participant at start and 11 weeks after start of intervention.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Self-Reported Emotional Quality of Life
Description
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.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Self-Reported Physical Quality of Life
Description
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.
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks
Title
Blodpressur, systolic and diastolic.
Description
Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks
Time Frame
At time of randomisation(March 1, 2010) and after 11 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ove Andren, PhD
Organizational Affiliation
OREBRO UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orebro University
City
Orebro
State/Province
Narke
ZIP/Postal Code
701-82
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21205749
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.
Results Reference
background
PubMed Identifier
20880998
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):801-807. doi: 10.1093/annonc/mdq443. Epub 2010 Sep 29.
Results Reference
background
PubMed Identifier
18202010
Citation
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.
Results Reference
background
PubMed Identifier
12928350
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. doi: 10.1093/jnci/djg009.
Results Reference
background
PubMed Identifier
17179483
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. doi: 10.1093/jnci/djj499.
Results Reference
background
PubMed Identifier
19910504
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.
Results Reference
background
PubMed Identifier
21115859
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.
Results Reference
background
PubMed Identifier
21640547
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.
Results Reference
background
PubMed Identifier
21798015
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.
Results Reference
background
Links:
URL
http://www.oru.se/English/
Description
Orebro University English Homepage
URL
http://www.hsph.harvard.edu/
Description
Harvard School of Public Health Homepage

Learn more about this trial

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

We'll reach out to this number within 24 hrs