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Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors

Primary Purpose

Thyroid Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Center-based exercise program
Home-based exercise program
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer.
  • English speaking
  • Able to provide consent

Exclusion Criteria:

  • Pregnant
  • Medullary thyroid cancer
  • Anaplastic thyroid cancer
  • Physical limitations to perform exercise

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Center-based exercise group

    Home-based exercise group

    Arm Description

    Subjects will be enrolled into a center-based exercise program.

    Subjects will be enrolled into a home-based exercise program.

    Outcomes

    Primary Outcome Measures

    Fatigue symptoms
    Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey
    Physical activity
    Change in physical activity measured using the self-reported International Physical Activity questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2020
    Last Updated
    June 6, 2022
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04224792
    Brief Title
    Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
    Official Title
    Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to pandemic, unable to see patients
    Study Start Date
    September 30, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Center-based exercise group
    Arm Type
    Experimental
    Arm Description
    Subjects will be enrolled into a center-based exercise program.
    Arm Title
    Home-based exercise group
    Arm Type
    Experimental
    Arm Description
    Subjects will be enrolled into a home-based exercise program.
    Intervention Type
    Other
    Intervention Name(s)
    Center-based exercise program
    Intervention Description
    A routine individualized exercise prescription and supervised exercise sessions at a minimum of once per week for 11 weeks with an exercise prescription updated monthly.
    Intervention Type
    Other
    Intervention Name(s)
    Home-based exercise program
    Intervention Description
    A one-time supervised exercise session with Cardiac Rehabilitation staff and a routine individualized exercise prescription for exercises to do at home. Additionally, weekly telephone followup calls by a clinical exercise physiologist for 11 weeks consisting of an exercise tip.
    Primary Outcome Measure Information:
    Title
    Fatigue symptoms
    Description
    Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey
    Time Frame
    Baseline, 12 weeks
    Title
    Physical activity
    Description
    Change in physical activity measured using the self-reported International Physical Activity questionnaire
    Time Frame
    Baseline, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer. English speaking Able to provide consent Exclusion Criteria: Pregnant Medullary thyroid cancer Anaplastic thyroid cancer Physical limitations to perform exercise
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Regina Castro, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors

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