Evaluation of Tolerance and Quality of Life in Patients With Neuroendocrine Tumors Treated With Oral Anti-Tumor Drugs Within a Therapeutic Education Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of the incidence of grade 3 to 5 adverse events in patients with neuroendocrine tumors treated with oral anti-tumor agents (ATO), based on their participation in a therapeutic education program
研究概览
简要总结
In recent years, the arrival of targeted oral therapies has greatly changed cancer treatment. These therapies help patients stay independent by reducing the number of hospital visits, since the treatment is given at home. However, this way of giving treatment brings specific challenges, especially in managing side effects and making sure patients follow their treatment properly.
Because of this, many patient education programs have been created to help patients learn how to manage their treatment on their own. Although only a few studies have formally looked at how useful these programs are, the available information suggests that they help patients handle side effects better and follow their treatment more closely.
Neuroendocrine tumors are a diverse group of tumors that are becoming more common. More patients with these tumors are now treated with targeted oral therapies such as everolimus, sunitinib, cabozantinib, or chemotherapy with temozolomide and capecitabine.
These treatments are often given together with a patient education program. However, so far, no study has specifically looked at how helpful these education programs are for this group of patients.
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
- •Adult patient (>18 years) at the time of the study
- •Patient diagnosed with a neuroendocrine tumor (NET) with an indication for treatment with oral anti-tumor agents (everolimus, sunitinib, cabozantinib, temozolomide +/- capecitabine, others including lenvatinib)
- •Collection of the patient's non-opposition to participate in the study
排除标准
- •Pregnant, parturient, or breastfeeding women
- •Persons deprived of liberty by judicial or administrative decision
- •Adults under legal protection measures (guardianship, conservatorship)
- •Refusal to participate in the study
结局指标
主要结局
Assessment of the incidence of grade 3 to 5 adverse events in patients with neuroendocrine tumors treated with oral anti-tumor agents (ATO), based on their participation in a therapeutic education program
时间窗: at 3 months
* Adverse effects (CTCAE v5.0) within 3 months following the initiation of ATO Grade 3-4 and 5 adverse effects: hematological, digestive, cutaneous, renal, hepatic toxicity (cytolysis \>5x normal), cardiovascular (including arterial hypertension and thromboembolic complications), pulmonary (interstitial lung disease), metabolic (including hyperglycemia, lipid profile abnormalities) * Actions taken at Month 1 and Month 3 Treatment suspension or delay of the cycle: number of suspensions, duration of suspension (in days) or number of cycle delays, duration of delay (in days) Dose reduction: reduction (yes/no), new dose Hospitalization due to adverse effects: number of hospitalizations, duration (total number of hospitalization days) * Description of patient follow-up and therapeutic patient education program Number of consultations: teleconsultation or in-person consultation, with nurse or physician (general practitioner or oncologist) Number of phone calls: with nurse or physician
次要结局
未报告次要终点