ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? Randomized Controlled Trial to Evaluate Patient Satisfaction and Cost-effectiveness of a Reduced Follow-up Schedule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 319
- 试验地点
- 47
- 主要终点
- Costs-effectiveness
研究概览
简要总结
Background: It has often been hypothesized that the frequency of follow-up for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking.
Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.
Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate).
Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.
Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival
Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated
Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders.
Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with Endometrioïd type endometrial carcinoma with stage 1 (FIGO, 2009) disease, with the following combination of stage, age and grade:
- •Stage 1A, any age, grade 1 or 2; Stage 1B, < 60 years, grade 1 or 2 without LVSI;
- •Written informed consent;
- •Sufficient oral and written command of the Dutch language.
排除标准
- •Any other stage and type of endometrial carcinoma
- •Histological types papillary serous carcinoma or clear cell carcinoma
- •Uterine sarcoma (including carcinosarcoma)
- •Radiotherapy for current endometrial carcinoma
- •Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
- •Confirmed Lynch syndrome
- •Previous pelvic radiotherapy
结局指标
主要结局
Costs-effectiveness
时间窗: assessed at 60 months after completion of primary treatment
Cost-effectiveness from the health care perspective using the EQ-5D
Patient satisfaction with follow-up care
时间窗: up to 60 months after completion of primary treatment
assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points
次要结局
- Costs-effectiveness(assessed at 36 months after completion of primary treatment)
- Anxiety and depression(assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment)
- Health-Related Quality of Live(assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment)
- Worry including fear of recurrence(assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment)
- Satisfaction with information provision(assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment)
- Illness perceptions(assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment)
- Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)(assessed at 60 months after completion of primary treatment)
- Survival(assessed at 60 months after completion of primary treatment)
- Health care use -gynaecologist, (specialist) nurse, primary care physician and other health or care services-; adherence to the indicated follow-up protocols; reasons for non-adherence(assessed at 6, 12, 36, and 60 months after completion of primary treatment)
- Time till recurrence(assessed at 60 months after completion of primary treatment)
研究者
Nicole Ezendam
Dr.
Comprehensive Cancer Centre The Netherlands