Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 5
- 主要终点
- 2-year compliance to the customized surveillance plan
研究概览
简要总结
This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).
详细描述
The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.
The secondary objectives are to compare between the two arms :
- Long-term compliance (5-year follow-up)
- Use of care
- Oncological events and their management
- Supportive care needs
The exploratory objectives are to :
- Evaluate the costs in terms of medical transportation
- Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
- Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
- Evaluate the reasons for recruitment failures
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
- None
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
- •Positive diagnosis (anatomopathology) of tumor within 12 months
- •Patient 18 years of age or older
- •Patient with one of the following conditions:
- •Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
- •Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
- •Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
- •Operated GIST with low risk of relapse
- •Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
- •Low-grade glioma, operated
- •Low-grade neuroendocrine tumor, treated by surgery alone
- •Patient who has given consent to participate in the study
排除标准
- •Contraindication to imaging tests required for the surveillance plan
- •No telephone
- •Patient under guardianship or curatorship
研究组 & 干预措施
Experimental
Telesurveillance by a nurse
干预措施: Oncological Follow-up (Other)
Control
On-site surveillance by a hospital physician
干预措施: Oncological Follow-up (Other)
结局指标
主要结局
2-year compliance to the customized surveillance plan
时间窗: 2 years
Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date
次要结局
- Occurrence and management of oncological events(5 years)
- Overall survival(5 years)
- Progression-free survival(5 years)
- 5-year compliance to the customized surveillance plan(5 years)
- Description of the use of care(5 years)
- Drop-out rate(5 years)
- Support care needs identified(2 years (early termination in case of relapse of the disease))