Clinical trial NCT04160650: Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Empowerment
Patient Activation
Self Care
Cancer of Colon
Cancer of Rectum
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2019-11-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* able to speak and understand Finnish
* receiving chemotherapy every three weeks in outpatient clinic: oxaliplatin+capecitabine= Xelox; irinotecan + capecitabine = Xeliri; Xelox or Xeliri + Bevacizumab

Exclusion Criteria:

* weak physical, psychological or cognitive function that prevents participation
* not able to understand Finnish

Primary outcomes:
measure: The rate of knowledge level (Knowledge test of malnutrition, nutrition impact side effects and their self-care, RasOma, Tuominen et al. 2019)
timeFrame: From the baseline to 8 and 16 weeks after the intervention
measure: The rate of self care activation (Patient Activation Measure PAM, Insignia Health; Hibbard et al. 2004)
timeFrame: From the baseline to 8 and 16 weeks after the intervention
Secondary outcomes:
measure: The incidence of malnutrition risk (Nutritional Risk Screening NRS2002, Kondrup et al. 2003)
timeFrame: From the baseline to 8 and 16 weeks after hte intervention
measure: The rate of quality of life (The Functional Assessment of Cancer Therapy Scale - Colorectal, FACT-C, Cella et al. 1993)
timeFrame: From the baseline to 8 and 16 weeks after the intervention
Other outcomes:
measure: Incidence of interruption, transfer and cancellation of the treatments
timeFrame: From the baseline to 8 and 16 weeks after the intervention
measure: Incidence of morbidity
timeFrame: From the baseline to 16 weeks after hte intervention
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: University of Turku
name: Helena Leino-Kilpi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuominen L, Ritmala-Castren M, Nikander P, Makela S, Vahlberg T, Leino-Kilpi H. Empowering patient education on self-care activity among patients with colorectal cancer - a research protocol for a randomised trial. BMC Nurs. 2021 Jun 10;20(1):94. doi: 10.1186/s12912-021-00617-z.