Fatigue Interventions in Cancer (Exercise Intervention)

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.

Inclusion Criteria:

- Diagnosed with (a) locally advanced or metastatic (stage III-IV) breast cancer or (b)
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 (< 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