Breast Cancer Clinical Trial

Fatigue Interventions in Cancer (Exercise Intervention)

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

126

Study ID:

NCT03421782

Recruitment Status:

Active, not recruiting

Sponsor:

University of Utah

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There is 1 Location for this study

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Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

126

Study ID:

NCT03421782

Recruitment Status:

Active, not recruiting

Sponsor:


University of Utah

How clear is this clinincal trial information?

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