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

Thyroid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02706743
• Other study ID #: ZMing
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2015
• Last updated: September 11, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Southern Medical University, China
• Contact: Sun Y Gang, Master
• Phone: 8602062783296
• Email: yungangsun[@]foxmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patients with differentiated thyroid cancer from baseline Medical Outcome Study Short-Form 36(MOS SF-36) questionnaire at 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	Yes
Primary	Change in patients with differentiated thyroid cancer from baseline Hospital Anxiety and Depression Scale at 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	Yes
Primary	Change in patients with differentiated thyroid cancer from baseline Brief Fatigue Inventory at 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	Yes