Educational Nursing Intervention on Nutrition Impact Side-effects' Self-care Among Patients With Colorectal Cancer During Chemotherapy: A Research Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- The rate of knowledge level (Knowledge test of malnutrition, nutrition impact side effects and their self-care, RasOma, Tuominen et al. 2019)
研究概览
简要总结
The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects may impact negatively on nutrition intake thus increase the risk of malnutrition and serious complications for patients. Purpose is to test the effect of empowering education on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and malnutrition.
A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and risk of malnutrition measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.
The study will provide knowledge of nurse-led educational intervention on self-care among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.
详细描述
The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects (nausea, vomiting, pain, mouth sores, fatigue, diarrhea, constipation, distress) may impact negatively on nutrition intake thus increase the risk of malnutrition thus serious complications for patients. Nurse-led empowering education may have positive effect on activation and knowledge level and enhance self-care of this patient group. Studies of nurse-led interventions that may enhance nutrition intake are scarce. Therefore, purpose of this study is to test the effect of educational nursing intervention on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and risk of malnutrition.
A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and malnutrition risk measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.
The study will provide knowledge of the effectiveness of nurse-led empowering educational intervention on self-care related to chemotherapy-induced side effects that may deteriorate nutrition intake among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.
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
- Single (Participant)
盲法说明
Participants are blinded after assignment to interventions, those in intervention and control groups are not aware which treatment they get.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to speak and understand Finnish
- •receiving chemotherapy every three weeks in outpatient clinic: oxaliplatin+capecitabine= Xelox; irinotecan + capecitabine = Xeliri; Xelox or Xeliri + Bevacizumab
排除标准
- •weak physical, psychological or cognitive function that prevents participation
- •not able to understand Finnish
结局指标
主要结局
The rate of knowledge level (Knowledge test of malnutrition, nutrition impact side effects and their self-care, RasOma, Tuominen et al. 2019)
时间窗: From the baseline to 8 and 16 weeks after the intervention
Knowledge is seen as essential for empowerment (Rankinen et al. 2014; Castro et al. 2016). It is assumed that knowledge level is better in the intervention group compared to control group. Knowledge test was developed in the research group, which included an oncologist, a dietitian, oncology nurses and a researcher. The instrument includes 15 items (yes/no, right answer=1 point, wrong answer=0 points).
The rate of self care activation (Patient Activation Measure PAM, Insignia Health; Hibbard et al. 2004)
时间窗: From the baseline to 8 and 16 weeks after the intervention
Activated individuals have the knowledge, skills and confidence to self-manage their health. PAM shows how ready, willing and able an individual is to manage his or her health and healthcare.It is assumed that patients in the intervention group are more activated to self-care their side effects. The activation score is based on a 0-100 point scale. A change of 3-4 points is associated with the difference between engaging and not engaging in particular behaviors. Activation self care is rated from 1 to 4 (1= low activation level; believing the patient role is important, 2=low activation level; having the confidence and knowledge necessary to take action, 3=moderate activation level; actually taking action to maintain and improve one's health, and 4=high activation level; staying the course even in stressful situations)(InsigniaHealth 2017).
次要结局
- The incidence of malnutrition risk (Nutritional Risk Screening NRS2002, Kondrup et al. 2003)(From the baseline to 8 and 16 weeks after hte intervention)
- The rate of quality of life (The Functional Assessment of Cancer Therapy Scale - Colorectal, FACT-C, Cella et al. 1993)(From the baseline to 8 and 16 weeks after the intervention)
研究者
Leena Tuominen
Principal Investigator
University of Turku