Fatigue Interventions in Cancer (Exercise Intervention)

Sponsor
University of Utah (Other)
Overall Status
Recruiting
CT.gov ID
NCT03421782
Collaborator
(none)
123
Enrollment
1
Location
2
Arms
60.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Cognitive Behavior Therapy
  • Behavioral: Exercise Intervention
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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.

  2. 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.

  3. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nonpharmacologic Interventions for Fatigue in Patients With Cancer
Actual Study Start Date :
Jan 17, 2018
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Exercise - 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.

Behavioral: Exercise Intervention
Undergo POWER exercise intervention

Experimental: Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)

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
Undergo PROSPECT internet-based CBT
Other Names:
  • CBT
  • cognitive therapy
  • CT
  • Behavioral: Exercise Intervention
    Undergo POWER exercise intervention

    Outcome Measures

    Primary Outcome Measures

    1. Change in fatigue [Baseline up to 12 weeks post intervention (24 weeks)]

      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.

    Secondary Outcome Measures

    1. Change in Quality of Life [Baseline up to 12 weeks post intervention (24 weeks)]

      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.

    2. Change in activity level [Baseline up to 12 weeks post intervention (24 weeks)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Huntsman Cancer Institute/University of UtahSalt Lake CityUtahUnited States84112

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Neeraj Agarwal, MD, Huntsman Cancer Institute/ University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Utah
    ClinicalTrials.gov Identifier:
    NCT03421782
    Other Study ID Numbers:
    • HCI105691
    • NCI-2017-02424
    First Posted:
    Feb 5, 2018
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021