Fatigue Interventions in Cancer (Exercise Intervention)

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVES: I. To evaluate the change in fatigue as assessed with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire with 12 weeks of exercise + internet-based intervention + usual care compared to exercise + usual care. SECONDARY OBJECTIVES: I. To compare the change in other patient-reported measures (e.g., insomnia, pain severity, physical function) as assessed with the PROMIS Profile 29 questionnaire with 12 weeks of exercise + internet-based intervention + usual care compared to exercise + usual care. II. To compare the change in activity level and associated parameters (e.g., graded exercise test) with 12 weeks of exercise + internet-based intervention + usual care compared to exercise + usual care. III. To examine associations between change in fatigue and change in activity level. 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.

Official Title
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Nonpharmacologic Interventions for Fatigue in Patients With Cancer

Conditions
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Sedentary Lifestyle, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Cancer AJCC v7

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy
* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Evidence of disease progression at the time of enrollment Treatment with cytotoxic chemotherapy within 3 months prior to enrollment Prior cognitive-behavioral therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise - Arm I<br>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. | Behavioral: Exercise Intervention<br>* Undergo POWER exercise intervention<br>|
| Experimental: Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)<br>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 CBT intervention over 12 weeks. | Behavioral: Cognitive Behavior Therapy<br>* Undergo PROSPECT internet-based CBT<br>* Other names: CT;Behavioral: Exercise Intervention<br>* Undergo POWER exercise intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue | Participant fatigue levels will be assessed at baseline, 6 weeks,12 weeks, and 24 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue. | Baseline up to 12 weeks post intervention (24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Participant quality of life will be assessed at baseline, 6 weeks, 12 weeks, and 24 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile v2.0. This questionnaire assesses depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. Raw scores range from 4-20, with higher scores indicating lower quality of life in that area, except for the sleep disturbance sub-section, where higher scores indicate better sleep. | Baseline up to 12 weeks post intervention (24 weeks) | 
| Change in activity level | At baseline, 6 weeks, 12 weeks, and 24 weeks, participants will be asked about their amount of time spent doing vigorous physical activity, moderate physical activity, walking, and sitting during the past 7 days. | Baseline up to 12 weeks post intervention (24 weeks) |