Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
June 6, 2022 updated by: M. Regina Castro, Mayo Clinic
Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Center-based exercise group
Subjects will be enrolled into a center-based exercise program.
|
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.
|
|
EXPERIMENTAL: Home-based exercise group
Subjects will be enrolled into a home-based exercise program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue symptoms
Time Frame: Baseline, 12 weeks
|
Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey
|
Baseline, 12 weeks
|
|
Physical activity
Time Frame: Baseline, 12 weeks
|
Change in physical activity measured using the self-reported International Physical Activity questionnaire
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Regina Castro, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 30, 2022
Primary Completion (ANTICIPATED)
September 30, 2024
Study Completion (ANTICIPATED)
December 30, 2024
Study Registration Dates
First Submitted
January 8, 2020
First Submitted That Met QC Criteria
January 8, 2020
First Posted (ACTUAL)
January 13, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-008397
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.