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

Not Applicable

Completed

• Conditions: Prostatic Neoplasm
• Interventions: Other: Standard of Care; Behavioral: Walking Intervention

• Registration Number: NCT01696539
• Lead Sponsor: Örebro University, Sweden

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-09
• Study First Submitted: 2012-09-16
• Study First Submitted QC: 2012-09-27
• Last Update Submitted: 2012-09-27
• Study First Posted: 2012-10-01
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
Walking Intervention	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.

Trial Locations

Locations (1)

Orebro University; 🇸🇪 Orebro, Narke, Sweden