The Effect of Education on Comfort and Anxiety Levels in Patients Receiving 5-FU Treatment Administered With an Elastomeric Pump: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Anxiety
研究概览
简要总结
Cancer is a chronic disease with an increasing global prevalence and high mortality rates. Surgical interventions, radiotherapy, and especially chemotherapy are among the main treatment modalities. Although chemotherapy prolongs survival, it also causes serious physical and psychological side effects. The prolonged and repetitive nature of chemotherapy necessitates safe vascular access, for which port catheters are frequently preferred. These subcutaneously implanted devices reduce the risk of complications and offer significant advantages in outpatient treatment settings.
5-Fluorouracil (5-FU), commonly used in the treatment of metastatic colorectal cancer, requires prolonged intravenous infusion to be effective. In this context, elastomeric pumps (EPs) are portable, user-friendly, non-electronic medical devices that allow for the continuous and controlled administration of 5-FU. EPs enable patients to continue chemotherapy at home, reducing hospital stays and enhancing both patient satisfaction and quality of life. However, environmental factors such as temperature, viscosity, and gravity may cause variations in flow rate, posing potential safety risks. Therefore, nurses must be competent in the use of EPs, patient education, and management of possible complications.
The use of EPs not only affects treatment efficacy but also has a significant impact on the comfort levels and anxiety of cancer patients. Home-based chemotherapy with EPs helps patients cope with uncertainty, fear, and stress associated with the diagnosis and treatment process. Delivering care outside the hospital environment reduces psychological burden and supports the individual's autonomy and social life. Thus, the wider implementation of EPs in 5-FU treatment and the active involvement of nurses in this process contribute substantially to both treatment outcomes and the overall patient experience. This study was designed to evaluate the impact of education provided to chemotherapy patients receiving 5-FU treatment via elastomeric pumps on their comfort and anxiety levels.
Hypotheses:
H1: There is a significant difference in comfort levels between patients educated about 5-FU treatment administered via elastomeric pumps and those receiving standard education.
H2: There is a significant difference in anxiety levels between patients educated about 5-FU treatment administered via elastomeric pumps and those receiving standard education.
H3: Certain variables have a significant effect on the comfort levels of chemotherapy patients receiving 5-FU treatment via elastomeric pumps.
H4: Certain variables have a significant effect on the anxiety levels of chemotherapy patients receiving 5-FU treatment via elastomeric pumps.
The study will be conducted as a randomized controlled trial. At study initiation, participants in both the intervention and control groups will complete the Patient Information Form, General Comfort Questionnaire-Short Form, Beck Anxiety Inventory, and Informed Consent Form during a face-to-face interview. Participants in the intervention group will additionally receive a 15-20 minute training session on the use of the elastomeric pump with 5-FU, based on a patient education booklet developed from current literature, delivered through verbal explanations and visual materials. The control group will follow standard institutional procedures without supplementary training. Follow-up assessments, including the General Comfort Questionnaire-Short Form and Beck Anxiety Inventory, will be re-administered to all participants during face-to-face interviews one month after baseline.
详细描述
Cancer is a chronic and fatal disease with an increasing global incidence. According to the 2022 Global Cancer Report prepared by the International Agency for Research on Cancer (IARC), a specialized agency of the World Health Organization, there were approximately 20 million new cancer cases and 10 million cancer-related deaths worldwide. Demographic projections estimate that the number of new cancer cases per year will rise to 35 million by 2050, representing a 77% increase compared to 2022 (International Agency for Research on Cancer [IARC]). Cancer is a progressive disease, and as it advances, patients may experience various physical and psychological symptoms. Many of these symptoms arise not from the disease itself but as side effects of chemotherapy (Temiz and Durna, 2020). Surgical interventions, radiotherapy, and chemotherapy are among the primary treatment methods for cancer. Although chemotherapy positively affects survival, it is also associated with severe physical and psychological side effects. Due to the long-term and repetitive nature of chemotherapy, ensuring safe intravenous administration of chemotherapeutic agents is crucial (Chefchaouni et al., 2023; Burucu and Polat, 2024).
A port catheter is a closed system consisting of a catheter that extends into the central vein, a subdermal reservoir connected to the catheter, and a specialized needle inserted from the dermis into the reservoir (Özden et al., 2012; Paleczny et al., 2013). Typically implanted over the upper pectoral muscle in the upper thoracic region (chest port), port catheters can also be placed in the upper arm or femoral (inguinal) region as alternatives (Paleczny et al., 2013; Pinelli et al., 2018). These subcutaneously implanted vascular access devices facilitate the infusion of chemotherapeutic agents, provide fluid support, and ensure long-term supportive care when needed. They allow for outpatient chemotherapy administration, enabling patients to return home on the same day, thereby increasing patient satisfaction (Burucu and Polat, 2024).
Given the extended duration of cancer treatment, port catheters are preferred over other central venous catheters. Their subcutaneous placement reduces the risk of complications such as occlusion, infection, dislocation, thrombosis, extravasation, phlebitis, and bleeding, and eliminates the need for dressing after wound healing (Odabas et al., 2014; Kesici et al., 2017; Pu Y-L et al., 2020). With specialized knowledge, attention, and experience, port catheters can be used safely for many years (Esfahani et al., 2015; Önder et al., 2014). While implantation is the responsibility of the clinician, needle insertion, catheter care, and initiating appropriate interventions in case of complications require a team effort in which nurses play a central role (Yeşil et al., 2014). Before port needle insertion, nurses inform patients and their families about the rationale for catheter insertion, the procedure, necessary precautions, possible complications, and symptoms. Patients sign an informed consent form. A detailed medical history is obtained, allergies are queried, and premedication is administered if necessary (Oran, 2009; Turan and Cantürk, 2013; Yeşilbalkan, 2005).
Needle access to the port may cause procedural pain and anxiety, reducing patient comfort. Healthcare professionals bear significant responsibility in minimizing these effects (Kutlu, 2015). Physicians and nurses must provide continuous education to patients and families to ensure optimal care (Yeşilbalkan, 2005). Accordingly, nurses' knowledge and experience regarding port catheter care are crucial. Nurses, as vital providers of healthcare, have critical responsibilities in safely performing interventions, preventing and detecting complications early, and educating patients and their families about catheter care (Öztaş et al., 2022). Studies show that informed patients experience less anxiety and fear, whereas uninformed patients are more affected by early-stage complications (Uslu et al., 2019).
5-Fluorouracil (5-FU) remains one of the most commonly used antineoplastic agents for advanced colorectal cancer. To exert its effect, 5-FU must be converted into a nucleotide. As an antimetabolite chemotherapy drug, 5-FU can be administered via intravenous infusion over 5-10 minutes, 20-60 minutes, or as continuous infusions over 22-24 hours for one to four days. Common side effects include bone marrow suppression, nausea, vomiting, anorexia, sore throat, hair loss, and diarrhea. Rare side effects include gait disturbances, eye irritation, confusion, severe allergic reactions, and cardiac complications such as acute coronary syndrome, cardiomyopathy, vasospastic angina, heart failure, arrhythmias, and sudden cardiac death. Cardiac effects usually subside after discontinuation of the infusion (Stewart et al., 2012; Shoemaker et al., 2004).
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
盲法说明
No masking was performed due to the nature of the educational intervention.
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
- •Diagnosed with cancer,
- •Able to understand Turkish and literate,
- •Medically fit to participate in the study,
- •Willing to participate in the study,
- •Aged 18 years or older.
排除标准
- •Diagnosed with a psychiatric disorder,
- •Unable to communicate effectively,
- •Refusing to participate in the study.
结局指标
主要结局
Anxiety
时间窗: 1 month
The primary outcome measure of this study is the change in anxiety levels, as assessed by the Beck Anxiety Inventory (BAI), from baseline to one month post-intervention. This measure evaluates the effectiveness of the elastomeric pump education on reducing patient anxiety during chemotherapy treatment with 5-FU.
次要结局
- Change in comfort levels from baseline to one month post-intervention, measured by the General Comfort Questionnaire-Short Form (GCQ-SF).(1 month)
研究者
Anita Karaca
Assist. Prof.
Biruni University
