Spots Global Cancer Trial Database for Fatigue Interventions in Cancer (Exercise Intervention)

Study Description

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 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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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