Follow-up of Endometrial Cancer Patients: A Valuable Medical Intervention or a Dispensable Force of Habit?
试验速览
- 阶段
- 不适用
- 入组人数
- 211
- 试验地点
- 4
- 主要终点
- Fear of Cancer Recurrence Inventory (questionnaire)
研究概览
简要总结
The present study is conducted, to elucidate the value of follow-up examinations in endometrial cancer patients. Specifically the objective is to compare hospital-based follow-up examinations with instruction in self-referral in stage I endometrial cancer patients.
The investigators hypothesize that the intervention, instruction in self-referral, will:
- reduce fear of recurrence
- improve quality of life
- improve cost-utility
- not affect disease-free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stage I Endometrial Cancer
排除标准
- •Dementia or other mental/cognitive impairment
- •Illiterate in Danish
- •Treated with adjuvant chemo- and/or radiotherapy
- •high risk histology
- •follow-up for other gynecologic malignancy
研究组 & 干预措施
Follow-up
Patients in this arm attend regular follow-up examinations, as is the current standard, at the department of gynecology following surgery.
Self-referral
Instead of regular follow-up examinations, this group is carefully instructed in alarm symptoms that require contact with a physician.
干预措施: Instruction in self-referral (Other)
结局指标
主要结局
Fear of Cancer Recurrence Inventory (questionnaire)
时间窗: change in score between 1, 10 and 34 months
次要结局
- Disease-free survival(3 years following treatment)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(change in score between 1, 10 and 34 months)
- EQ-5D-5L(change in score between 1, 10 and 34 months)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Endometrial cancer Module (EORTC QLQ-EN24)(change in score between 1, 10 and 34 months)
- Items on Unmet needs from the "Coherence for cancer patients questionnaire"(change in score between 1, 10 and 34 months)
- Incidence of disease recurrence(3 years following treatment)
- Posttraumatic Growth Inventory(change in score between 1, 10 and 34 months)
- Resource use at hospital, primary care and use of medicinal products(During the three years following treatment)
研究者
Mette Moustgaard Mathiesen
PhD student
Odense University Hospital