NCT03421782

Fatigue Interventions in Cancer (Exercise Intervention)

Nonpharmacologic Interventions for Fatigue in Patients With Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 that has spread to other places in the body and usually cannot be cured or controlled with treatment. Exercise intervention and internet-based cognitive behavior therapy may help to improve feelings of tiredness in participants with prostate cancer. The study originally included both prostate cancer and breast cancer participants, but due to low accrual of breast cancer participants, the breast cancer cohort was closed and the study continued with prostate cancer participants only.

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 exercise program. SECONDARY OBJECTIVES: I. To evaluate the change in fatigue from baseline to week 12 in patients with prostate cancer who completed both baseline and 12 week assessments, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program. II. To evaluate the change in cardiorespiratory fitness from baseline to Week 12, as assessed with the graded exercise test, with 12 weeks of the POWER exercise program. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. ARM II: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based cognitive behavior therapy (CBT) intervention over 12 weeks. After completion of study, patients are followed up every 6-12 months for 2 years. Because of challenges with the PROSPECT intervention, including multiple periods of time during which the intervention was not available and loss of data about use of the intervention by participants because of a computer virus, it appears that the majority of patients randomized to that arm of the study did not actually use the intervention. Therefore evaluable participants will be combined and analyzed as a single cohort.

Conditions

• Sedentary Lifestyle
• Stage III Prostate Cancer AJCC v7
• Stage IV Prostate Cancer AJCC v7

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavior Therapy	Undergo PROSPECT internet-based CBT
BEHAVIORAL	Exercise Intervention	Undergo POWER exercise intervention

Timeline

• Start date: 2018-02-26
• Primary completion: 2022-04-25
• Completion: 2022-08-08
• First posted: 2018-02-05
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States