Status:
COMPLETED
Fatigue Interventions in Cancer (Exercise Intervention)
Lead Sponsor:
University of Utah
Conditions:
Sedentary Lifestyle
Stage III Prostate Cancer AJCC v7
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer tha...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of POWER exerc...
Eligibility Criteria
Inclusion
- Diagnosed with advanced prostate cancer
- Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment
- A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??
- Sedentary activity pattern (Average \< 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year
- Physically able to exercise and physician consent to start an exercise program
- Regular access to a computer with internet service
- Must be able to read and understand English
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion
- Evidence of disease progression at the time of enrollment
- Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
- Prior cognitive-behavioral therapy
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03421782
Start Date
February 26 2018
End Date
August 8 2022
Last Update
March 20 2024
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112