HRQOL in Locally Advanced Thyroid Carcinoma (LATCQOL)

April 11, 2023 updated by: Fujian Cancer Hospital

Health-related Quality of Life of Patients With Locally Advanced Thyroid Cancer Receiving Targeted Therapy

The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgical resection is the cornerstone of treatment for thyroid cancer. However, some patients present with locally advanced disease at the time of diagnosis, and they are not eligible for radical resection. Another patients still had the risk of recurrence after surgery, endocrine therapy and iodine-131 treatment. Tyrosine kinase inhibitors (TKI) have been proved to be effective in thyroid cancer patients. However, it was still unclear whether TKI drugs had influence on the HRQOL of LATC patients. The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).Participants enroll the study after informed consent, and quality of life will be assessed using quality of life questionnaires EORTC QLQ C30, and EORTC THY 47 before surgery, and 1,3,6 and 12 months after treatment.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

locally advanced thyroid cancer

Description

Inclusion Criteria:

  • Patients age (18-70 year old)
  • Diagnosis of locally advanced thyroid cancer
  • Patient receiving TKI drugs.

Exclusion Criteria:

  • pregnancy or breastfeeding women;
  • history of other malignant diseases, unstable angina, myocardial infarction, cerebral infarction or cerebral hemorrhage within 6 months; (3) patients missing questionnaires greater than 3 times.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TKI group
patients with LATC receiving Tyrosine kinase inhibitor drugs.
Drug: Tyrosine kinase inhibitor drugs.
TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.
Other Names:
  • TKI treatment
Controlled group
patients with LATC receiving other treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the global status of QLQ C30 questionnaire
Time Frame: 1 year
Change in global HRQOL score between baseline and at 12 months after treatment. A change of more than 10% is set as a limit for a significant change
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adversed events of TKI.
Time Frame: 1 year
all TKI-related adversed events during and after the treatment of TKI.
1 year
Change in fatigue score
Time Frame: 1 year
Change in fatigue score between start and at 12 months after thyroid treatment. A change of more than 10% is set as a limit for a significant change.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Investigators

  • Study Chair: Hui Liu, FujianMedical University Cancer Hospital

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 (Actual)

February 1, 2023

Primary Completion (Anticipated)

January 31, 2025

Study Completion (Anticipated)

January 31, 2026

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJCH_HNS_QOL01

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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