Fatigue Interventions in Cancer (Exercise Intervention)

NCT03421782 | Completed Phase 2 DMC

• 2 other identifiers: HCI105691NCI-2017-02424
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle; Stage III Prostate Cancer AJCC v7; Stage IV Prostate Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Quality of Life

  Baseline up to 12 weeks post intervention (24 weeks)

• Change in activity level

  Baseline up to 12 weeks post intervention (24 weeks)

Study Arms (2)

Exercise - Arm I

EXPERIMENTAL

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

Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)

EXPERIMENTAL

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; Behavioral: Exercise Intervention

Interventions

Cognitive Behavior Therapy BEHAVIORAL

Undergo PROSPECT internet-based CBT

Also known as: CBT, cognitive therapy, CT

Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)

Exercise Intervention BEHAVIORAL

Undergo POWER exercise intervention

Exercise - Arm I; Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Evidence of disease progression at the time of enrollment
• Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
• Prior cognitive-behavioral therapy

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Prostatic Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Umang Swami, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 26, 2018
• Primary Completion: April 25, 2022
• Study Completion: August 8, 2022
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)