Evaluation of Central Venous Catheters Used for Chemotherapy in Women With Breast Cancer - An Interdisciplinary Randomized Controlled Study of Complications, Material Wear, Staff- and Patient Perspectives, and Health Economy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
The overall aim of this study is to evaluate two different central venous lines, PICC-lines (PICC) and subcutaneous venous access ports (SVAP) used for chemotherapy in women with breast cancer. The study will compare complications, material wear of the catheters used, patients'- and health care professionals' experiences, and costs. The study will give knowledge about which central venous access that is the most advantageous regarding adjuvant chemotherapy for women with breast cancer in the aspects of safety, quality of care, and quality of life.
详细描述
N=250 women between 18 and 70 years of age with invasive breast cancer who are allocated to adjuvant or neo adjuvant chemotherapy during 18 weeks at the Department of Oncology at Karolinska University Hospital , Stockholm Sweden are eligible to participate in the present study. Exclusion criteria are cognitive dysfunction and/or inability to understand Swedish. Before participation an informed consent will be collected. The patients will be randomized to receive a PICC or a SVAP. Complications will be registered as well as the treatments.
Bacterial cultures will be taken at removal of PICC/SVAP. The used PICC/SVAP will be transported to the Royal Institute of Technology (KTH) and subjected to material analyses. Comparison with reference materials from the in-vitro study and with new reference catheters will be performed. Patient assessments with questionnaire concerning HRQL, illness perception, body imaging, life style and sleep disturbance will be collected at baseline and at the last chemotherapy session. Interviews with the patients about life situations will be conducted half through the chemotherapy treatment period.In- and out-patients costs, i.e. medication, materials, costs related to the care of the PICC/SVAP, costs for complications, additional costs for the patients regarding the treatment, etc., will be monitored and registered. In- and out-patient costs will also be monitored. Data from medical records concerning treatments for complications will also be taken into consideration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adjuvant or neo adjuvant chemotherapy,
- •speak Swedish
排除标准
- •cognitive dysfunction
- •and/or inability to understand Swedish,
- •recurrent breast cancer
研究组 & 干预措施
PICC-Line
Women allocated to PICC-line when receiving chemotherapy
干预措施: FEC75 (or EC90) x 6 (Drug)
PICC-Line
Women allocated to PICC-line when receiving chemotherapy
干预措施: FEC100 + Taxotere (EC90 + Taxotere) 3+3 (Drug)
PICC-Line
Women allocated to PICC-line when receiving chemotherapy
干预措施: Paclitaxel (Drug)
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
干预措施: FEC75 (or EC90) x 6 (Drug)
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
干预措施: FEC100 + Taxotere (EC90 + Taxotere) 3+3 (Drug)
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Complications
时间窗: Through study completion up to 18 weeks
all complications during the chemotherapy treatment period are registered
次要结局
- Questionnaire EQ-5D(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Questionnaire EORT-QLQ 30(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Questionnaire EORT-QLQ BR32(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Questionnaire Insomnia Symptom Score(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Body Esteem Scale (BES)(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Enriched Social Support Instrument (ESSI)(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Brief-Illness Perception Questionnaire (B-IPQ)(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
研究者
Gunilla Bjorling
Professor
Swedish Red Cross University College
