NCT04224792

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2.7 years until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

January 8, 2020

Last Update Submit

June 6, 2022

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

  • Fatigue symptoms

    Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey

    Baseline, 12 weeks

  • Physical activity

    Change in physical activity measured using the self-reported International Physical Activity questionnaire

    Baseline, 12 weeks

Study Arms (2)

Center-based exercise group

EXPERIMENTAL

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

Other: Center-based exercise program

Home-based exercise group

EXPERIMENTAL

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

Other: Home-based exercise program

Interventions

Center-based exercise programOTHER

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.

Center-based exercise group
Home-based exercise programOTHER

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.

Home-based exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Regina Castro, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

September 30, 2022

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share