NCT06435546已完成不适用
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study
Institut de Cancérologie de Lorraine2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
研究概览
简要总结
AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Adult over 18 years old.
- •Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
- •Oral anticancer medications started for at least 3 months.
- •With a performance status ≤
- •Patient has understood, signed and dated the consent form.
- •Patient covered by the social security system.
排除标准
- •Patient with early breast cancer or localized prostate cancer.
- •Patient with life expectancy < 3 months.
- •Patient in progression
- •Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
- •Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
- •Patient unable to read or speak French.
- •Patient already included in another therapeutic trial with an experimental molecule.
- •Persons deprived of their liberty or under guardianship (including curatorship).
结局指标
主要结局
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
时间窗: one day
Medication adherence to oral anticancer treatments will be assessed using a score based on the GIRERD adherence assessment (targeting oral anticancer treatments). The score is a scale ranging from 0 to 6 (good compliance = 6; poor compliance = 4 to 5; non-adherence ≤ 3).
次要结局
- Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if HADS scale is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if MNA is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if biological markers are associated with reduced adherence to oral anticancer treatments(one day)
- Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if comorbitities is associated with reduced adherence to oral anticancer treatments(one day)
- Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments(one day)
- Describe and compare medication adherence to oral treatments(one day)
- Describe and compare patient characteristics (socio-demographic, clinical and contextual), medication adherence to oral anticancer treatments according to cancer type, use of alternative and complementary medicines and use of social media and networks.(one day)
- Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.(one day)
- Study the relationship between the two adherence questionnaires.(one day)
研究者
研究点 (2)
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