Assessment of Quality of Life After Adjunct Radioiodine Therapy in Patients With Differentiated Thyroid Cancer

September 11, 2016 updated by: Sun Yungang, Southern Medical University, China

Effect of Radioiodine Remnant Ablation on Quality of Life in Patients With Differentiated Thyroid Cancer:a Prospective Cohort Study

The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the quality of life(QOL) in differentiated thyroid cancer patients and to identify independent factors affecting changes in the QOL.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

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 Contact Backup

  • Name: OU Y Wei, Master
  • Phone Number: 61643888 8613600474406
  • Email: oyw88@sina.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital,Southern Medical University
        • Contact:
        • Principal Investigator:
          • Sun Y Gang, Master

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with differentiated thyroid cancer initially referred to adjuvant radioiodine treatment in nuclear medicine department, Zhujiang Hospital, Southern Medical University.

Description

Inclusion Criteria:

  • Pathologically confirmed new diagnosis of differentiated thyroid cancer, recently treated by total thyroidectomy
  • Must sign a consent form before treatment
  • One year or more of follow-up after radioiodine ablation

Exclusion Criteria:

  • Patients with follicular, Hürthle cell, poorly differentiated, medullary, or anaplastic thyroid carcinoma
  • Pregnant or lactating women
  • Patients that received adjuvant radioiodine treatment in the past
  • Patients with other cancer

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patients with differentiated thyroid cancer from baseline Medical Outcome Study Short-Form 36(MOS SF-36) questionnaire at 12 months
Time Frame: baseline and 12 months
The Medical Outcome Study Short-Form 36(MOS SF-36) is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems(four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
baseline and 12 months
Change in patients with differentiated thyroid cancer from baseline Hospital Anxiety and Depression Scale at 12 months
Time Frame: baseline and 12 months
The Hospital Anxiety and Depression Scale HADS is a self-rated screening questionnaire detecting mild degrees of anxiety and depression. It consists of 14 questions, seven for anxiety and seven for depression. Scores range from non-cases (0-7 score), borderline cases(8-10 score), definite cases (11-21 score).
baseline and 12 months
Change in patients with differentiated thyroid cancer from baseline Brief Fatigue Inventory at 12 months
Time Frame: baseline and 12 months
The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.The BFI consists of 9 items on a single page. Fatigue and its interference are measured on numeric scales from 0-10. There are three items asking subjects to describe their fatigue now, at its usual level, and at its worst level during the previous 24 hours, using extreme points "no fatigue" and "fatigue as bad as you can imagine." The next six items describe how much fatigue has interfered with aspects of their life during the previous 24 hours. Specifically, these items are general activity, mood, walking ability, normal work (both work outside the home and daily chores), relations with other people, and enjoyment of life. These interference scales range from "0" ("does not interfere") to "10" ("completely in terferes"). The global score for the BFI is calculated as the mean value of these 9 items.
baseline and 12 months

Collaborators and Investigators

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

Sponsor

Southern Medical University, China

Investigators

  • Principal Investigator: Sun Y Gang, Master, Zhujiang 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

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 11, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZMing

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.

Clinical Trials on Thyroid Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe