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Completed

NCT Number: NCT01696539

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

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.

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Key information

Conditions

Prostatic Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Orebro University

Örebro, Narke, 701-82, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of care

Other

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

Secondary outcomes

  1. C-Reactive Protein

    Time frame: 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.

  2. High-Density Lipoprotein

    Time frame: 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.

  3. Adiponectin

    Time frame: 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.

  4. Total Cholesterol

    Time frame: 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.

  5. Triglycerides

    Time frame: 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.

  6. Insulin

    Time frame: 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.

  7. Testosterone

    Time frame: 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.

  8. Estradiol

    Time frame: 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.

  9. Self-Reported Stress

    Time frame: 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.

  10. Self-Reported Sleep Quality

    Time frame: At time of randomisation(March 1, 2010) and after 11 weeks

    Self-reported sleep quality measured using the Karolinska Sleepiness Scale. Questionnaire completed by participant at start and 11 weeks after start of intervention.

  11. Self-Reported Emotional Quality of Life

    Time frame: At time of randomisation(March 1, 2010) and after 11 weeks

    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.

  12. Self-Reported Physical Quality of Life

    Time frame: At time of randomisation(March 1, 2010) and after 11 weeks

    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.

  13. Blodpressur, systolic and diastolic.

    Time frame: At time of randomisation(March 1, 2010) and after 11 weeks

    Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Harvard School of Public Health (HSPH)

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2012
Registry last updated
Oct 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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