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Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

NCT04160650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-05-27

No results posted yet for this study

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.

Conditions

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

Interventions

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?

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • University of Turku

    lead OTHER

Principal Investigators

  • Helena Leino-Kilpi, PhD · University of Turku

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2022-03-15
Completion
2022-03-15

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160650 on ClinicalTrials.gov