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Withdrawn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
About this trial
This is an interventional supportive care trial for Thyroid Cancer
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
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
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Withdrawn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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