Health Related Quality of Life in Thyroid Cancer Patients, and in Patients With Thyroid Nodules Suspicious of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in global HRQOL score
研究概览
简要总结
Background: Most patients with thyroid cancer have a long life expectancy, and it has been assumed among health professionals that therefore the quality of life (QOL) is good. Some European studies have shown that the quality of life among thyroid cancers is worse than the general population, and almost as low as other cancer diagnoses, with a worse prognosis and a more burdening treatment.
Aim: To examine prospectively the quality of life in participants undergoing diagnostic thyroid surgery and participants undergoing surgery for certain thyroid cancer. By examining both groups we wish to find answers if quality of life is affected, and if so - mostly affected by the diagnosis or the surgery itself.
Methods: Participants enroll the study after informed consent, and quality of life will be assessed using quality of life questionnaires EORTC QLQ C30, EORTC THY 47 and EORTC FA12 before surgery, and 6 and 12 months after surgery. This study will form two main groups of participants; with and without thyroid cancer.
详细描述
Most patients with thyroid cancer have a long life expectancy, and it has been assumed among health professionals that therefore the quality of life (QOL) is good. Some European studies have shown that the QOL among thyroid cancers is worse than the general population, and almost as low as other cancer diagnoses, with a worse prognosis and a more burdening treatment.
This study aims to examine the quality of life in patients undergoing diagnostic surgery for thyroid tumour(s), or thyroid surgery as part of a cancer treatment.
Participants will undergo standard work up and treatment for their thyroid tumour(s). Clinical data will be extracted from medical records at Oslo University Hospital (OUH). Questionnaires on Health related quality of life (HRQOL) are be filled out before surgery and at follow up visits at 6 and 12 months after surgery. Participants that do not meet at follow-up, will receive the questionnaires by mail.
At the end of the study there will be three subgroups of participants: (a) Benign tumour, (b) Malignant tumour with radioiodine treatment, (c) Malignant tumour without radioiodine treatment.
Questionnaires from European Organization for Research and Treatment of Cancer (EORTC) will be used, as they are well validated and relatively widely used. The EORTC QLQ C30 was chosen for a general view on HRQOL, as well as an available Norwegian general population for comparison. For a more disease specific questionnaire, the EORTC THY47 is used, a module of EORTC QLQ C30 on thyroid cancer. In addition we wish to capture a possibly important element in participants undergoing thyroid surgery, and where a fraction of participants may be hypothyroid for a period of time - therfore a fatigue module, the EORTC FA12 was added.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned hemi- or total thyroidectomy at the ENT-Department of Oslo University Hospital
- •tumour in the thyroid gland With fine needle aspiration results of Bethesda 3-6, or other clinical manifestations suspicious of cancer.
- •ability to understand and Complete the quesitionnaires
- •informed consent to participation
排除标准
- •unable to Complete or understand the questionnaires
- •age below 18 years
- •thyroid surgery within the last 2 years
- •thyroid surgery on other indications than listed above
- •participants With postoperative external radiotherapy
结局指标
主要结局
Change in global HRQOL score
时间窗: Circa 12 months from date of (last) thyroid surgery for the individual participant
Change in global HRQOL score between start and at 12 months postoperatively after thyroid surgery. A change of more than 10% is set as a limit for a significant change.
次要结局
- Change in fatigue score(Circa 12 months from date of (last) thyroid surgery for the individual participant)
- Change in HRQOL between participants With benign and malignant tumours(Circa 12 months from date of (last) thyroid surgery for the individual participant)
- Change in HRQOL before and after radioiodine treatment(Circa 12 months from date of (last) thyroid surgery for the individual participant)
研究者
Bianca M.R. Lorntzsen
MD, PhD candidate
Oslo University Hospital