Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Survival adjusted for quality of life
研究概览
简要总结
The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in patients with advanced cancer who have already received at least a first course of chemotherapy but had proven therapeutic failure.
The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to quality-of-life-adjusted survival compared to a comprehensive care program.
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
- 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
- •Men and women ≥18 years of age.
- •Patients potentially eligible to receive a new chemotherapy cycle and whose clinical condition, according to the oncologist, does not identify any therapeutic strategy clearly superior to another, in the light of scientific evidence.
- •Patients with advanced cancers that have been treated with chemotherapy but who have not displayed complete response to treatment or who, after treatment response, are now in a situation of recurrence or disease progression
- •Patients who have previously received at least one chemotherapy cycle of the following tumors:
- •Cancer of the digestive and gastrointestinal tract
- •Head and Neck Cancer
- •Lung cancer
- •Urologic cancers
- •Gynecologic cancers
- •Central nervous system cancer
- •Patients who can potentially comply with study and/or monitoring procedures and to accept and sign the informed consent form.
- •Patients whose home is located less than 10 km, approximately, of the hospitals participating in the study.
排除标准
- •Patients who are currently receiving chemotherapy, although patient pursuing any other concomitant treatment are eligible (eg, hormone therapy or radiation therapy).
- •Patients who have contraindications to chemotherapy.
- •Patients who did not agree to participate in the clinical trial
研究组 & 干预措施
Integral Attention Program (PAI)
The key points of the PAI are:
- To assess and manage pain and other symptoms resulting from disease progression.
- To evaluate the information needs that may arise and to address them.
- To encourage patient and family adaptation to the situation of advanced disease and in the terminal phase of it.
- To provide guidance in decision-making while respecting patient autonomy.
- To establish a plan of care and treatment, adapted to the evolution and needs of the patient.
- To promote continuity of care.
干预措施: Integral Attention Program (PAI) (Other)
Standard Palliative Chemotherapy and PAI
Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.
干预措施: Standard Palliative Chemotherapy (Drug)
Standard Palliative Chemotherapy and PAI
Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.
干预措施: Integral Attention Program (PAI) (Other)
结局指标
主要结局
Survival adjusted for quality of life
时间窗: At one year of follow-up
Quality of life will be measured by the EuroQoL-5D questionnaire.
次要结局
- Patient satisfaction regarding care using a Likert scale of 5 items (very satisfied, satisfied, neither satisfied or dissatisfied, somewhat satisfied and not satisfied).(At one year of follow-up)
- Specific Quality of life: measured through the quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ C-30) and Palliative Care Scale (POS)(At one year of follow-up)
- Control of symptoms using the Edmonton Symptom Assessment System(At one year of follow-up)
- Costs reported by the information system of each hospital(At the end of follow-up)
- Adverse effects related to study interventions(At one year of follow-up)
- Toxicity by the American National Cancer Institute toxicity(At one year of follow-up)