Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Toxicity score
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a nurse telephone interview in the management of cancer patients treated by oral chemotherapy. This is a multicenter prospective randomized controlled pragmatic interventional trial conducted in collaboration with two oncology care facilities. Eligible population consists of all patients suffering from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients will be enrolled in the study. The experimental group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care, and telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care.
The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity grades).
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
- •aged over 18 years
- •treated in medical oncology, hematology or radiotherapy
- •to receive any oral chemotherapy for any cancer except hormone therapy according to decision of the Meeting of Consultation Multidisciplinary
排除标准
- •Refusal of participation, protected adult patient under guardianship.
- •Patient currently treated with oral chemotherapy
- •Patient already included in another clinical research protocol including telephone follow-up
- •Patient followed by a Nurse navigators or participating in a therapeutic education program
- •Patient concomitantly treated with an injectable chemotherapy regimen or radiotherapy unless irradiation palliative analgesic.
- •Patient in inability to understand how the study or inability to follow a telephone conversation.
- •Patient with documented history of cognitive or psychiatric disorders.
- •Patient residing outside the Rhône Alpes area
- •Patient doesn't understand French
- •Patient with no phone means
研究组 & 干预措施
Nurse phone call
a nurse will interview patients by phone every 14 +/- 2 days for 6 months
干预措施: Nurse phone call (Behavioral)
Control Group
Common practice
结局指标
主要结局
Toxicity score
时间窗: 6 months
Toxicity Score 9 most common side effects of oral chemotherapy (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from the NCI-CTCAE v4.0 (Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 toxicity grades)
次要结局
未报告次要终点