Fatigue Interventions in Cancer (Exercise Intervention)

Sedentary Lifestyle Clinical Trial

Official title:

Nonpharmacologic Interventions for Fatigue in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421782
• Other study ID #: HCI105691
• Secondary ID: NCI-2017-02424
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2018
• Est. completion date: August 8, 2022

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 8, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Sedentary Lifestyle
• Stage III Prostate Cancer AJCC v7
• Stage IV Prostate Cancer AJCC v7

Intervention

Behavioral:
• Cognitive Behavior Therapy
Undergo PROSPECT internet-based CBT
• Exercise Intervention
Undergo POWER exercise intervention

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue	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 the POWER exercise program.	Baseline up to 12 weeks post intervention (24 weeks)
Secondary	Change in Quality of Life	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.	Baseline up to 12 weeks post intervention (24 weeks)
Secondary	Change in activity level	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.	Baseline up to 12 weeks post intervention (24 weeks)