NCT04160650

Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Patient Empowerment
• Patient Activation
• Self Care
• Cancer of Colon
• Cancer of Rectum

Interventions

Type	Name	Description
BEHAVIORAL	Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer	This is an educational intervention which aims to answer the questions: 1. In patients with CRC what is the effect of empowering education versus standard education on knowledge level in 4 months follow-up? 2. In patients with CRC what is the effect of empowering education versus standard education on activation level related to nutrition impact side effects' self-care in 4 months follow-up? 3. In patients with CRC what is the effect of empowering education versus standard education on malnutrition risk in 4 months follow-up? 4. In patients with CRC what is the effect of empowering education versus standard education on QoL in 4 months follow-up?

Timeline

• Start date: 2019-10-21
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2019-11-13
• Last updated: 2022-05-27

Locations

1 site across 1 country: Finland