Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy
NCT ID: NCT04160650
Last Updated: 2022-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2019-10-21
2022-03-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Educational nursing intervention
Patients in experimental group receive standard care and one-hour educational session. Patients are provided knowledge of
* healthy diet
* malnutrition, its prevalence and consequences for patients with CRC undergoing CT
* side effects impairing nutrition intake during CT treatment.
* prevention and self-care methods of the side effects Teach-back is used to verify participants' understanding. Empowering effect is confirmed by using active listening and asking patients' individual side effects, self-care strategies and need of additional knowledge in the beginning of the session and supporting patients' self-care methods when they have been applicable and effective. Additional knowledge of each theme is offered. To reinforce the intervention effect patients receive after the first CT a self-monitoring diary including assessment of side effects prevalence and intensity (NRS 0-10) before and after the self-care strategies. They return diaries by the 5th cycle of CT.
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?
Standard care
Patients in control group receive standard care, information of
* general CT induced side effects and their self-care; nausea, diarrhoea, obstipation and sores in the mouth, peripheral neuropathy symptoms, local venous irritation, heart symptoms, mucous and skin irritation
* side-effects' self-monitoring, fluid intake, medication dose changes, effect of CT
* weight control
* taste alteration
* cold sensitivity
* variable diet
* dietary supplements
* available dietitian services
They receive a self-monitoring diary, which includes only side effects and their intensity (NRS 0-10).
No interventions assigned to this group
Interventions
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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?
Eligibility Criteria
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Inclusion Criteria
* receiving chemotherapy every three weeks in outpatient clinic: oxaliplatin+capecitabine= Xelox; irinotecan + capecitabine = Xeliri; Xelox or Xeliri + Bevacizumab
Exclusion Criteria
* not able to understand Finnish
18 Years
85 Years
ALL
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
University of Turku
OTHER
Responsible Party
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Leena Tuominen
Principal Investigator
Principal Investigators
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Helena Leino-Kilpi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Turku
Locations
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Helsinki University Hospital
Helsinki, , Finland
Countries
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References
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Tuominen L, Ritmala M, Vahlberg T, Makela S, Nikander P, Leino-Kilpi H. The effect of nurse-led empowering education on nutrition impact side effects in patients with colorectal cancer undergoing chemotherapy: A randomised trial. Patient Educ Couns. 2023 Oct;115:107895. doi: 10.1016/j.pec.2023.107895. Epub 2023 Jul 15.
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.
Other Identifiers
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NursEff
Identifier Type: -
Identifier Source: org_study_id
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