Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy
Condition: Patient Empowerment; Patient Activation; Self Care; Cancer of Colon; Cancer of Rectum
MeSH terms: Colonic Neoplasms; Rectal Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer
Intervention type(s): Behavioral
Intervention description(s): This is an educational intervention which aims to answer the questions:
In patients with CRC what is the effect of empowering education versus standard education on knowledge level in 4 months follow-up?
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?
In patients with CRC what is the effect of empowering education versus standard education on malnutrition risk in 4 months follow-up?
In patients with CRC what is the effect of empowering education versus standard education on QoL in 4 months follow-up?
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures
Masking: Single (Participant)
Primary purpose: Supportive Care