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Withdrawn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.
Other: 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.
Other: 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

Mayo Clinic

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.

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