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临床试验/NCT02706743
NCT02706743Unknown不适用

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

Southern Medical University, China1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Change in patients with differentiated thyroid cancer from baseline Medical Outcome Study Short-Form 36(MOS SF-36) questionnaire at 12 months

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Change in patients with differentiated thyroid cancer from baseline Medical Outcome Study Short-Form 36(MOS SF-36) questionnaire at 12 months

时间窗: 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).

Change in patients with differentiated thyroid cancer from baseline Hospital Anxiety and Depression Scale at 12 months

时间窗: 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).

Change in patients with differentiated thyroid cancer from baseline Brief Fatigue Inventory at 12 months

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Southern Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun Yungang

Principal Investigator

Southern Medical University, China

研究点 (1)

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