Exercise Intervention with or without Internet-Based Cognitive Behavior Therapy in Reducing Fatigue in Patients with Advanced Prostate Cancer

PRIMARY OBJECTIVE:

I. To evaluate the change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire, with 12 weeks of the Personal Optimism with Exercise Recovery (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.

EXPLORATORY OBJECTIVES:

I. To compare the change in other patient-reported measures (e.g., insomnia, pain severity, physical function) from baseline to week 12 as assessed with the PROMIS Profile 29 with 12 weeks of the POWER exercise program.

II. To evaluate the change from baseline to week 12 in overall quality of life, as assessed with the Functional Assessment of Cancer Therapy General – 7 (FACT G7) questionnaire, with 12 weeks of the POWER exercise program.

III. To evaluate the change from baseline to week 12 in fatigue, as assessed with the Patient Global Impression of Change (PGIC) questionnaire, with 12 weeks of the POWER exercise program.

IV. To compare the change in exercise parameters (e.g., timed get up and go, chest press) with 12 weeks of the POWER exercise program.

V. To examine associations between change in fatigue and baseline characteristics (e.g., age, baseline graded exercise test).

VII. To examine associations between change in fatigue and change in exercise parameters (e.g., graded exercise test, timed get up and go, chest press).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 45-60 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 45-60 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.