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NCT04160650

Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

Completed NA Last updated 27 May 2022
What this trial tests

NA trial testing Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer in Patient Empowerment in 82 participants. Completed in 15 March 2022.

Timeline
21 October 2019
Primary endpoint
15 March 2022
15 March 2022

Quick facts

Lead sponsorUniversity of Turku
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment82
Start date21 October 2019
Primary completion15 March 2022
Estimated completion15 March 2022
Sites1 location across Finland

Drugs / interventions tested

Conditions studied

Sponsor

University of Turku

Who can join

Adults 18 to 85, any sex, with Patient Empowerment or Patient Activation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Empowering patient education on self-care activity among patients with colorectal cancer - a research protocol for a randomised trial.
    Tuominen L, Ritmala-Castrén M, Nikander P, Mäkelä S, et al · · 2021 · cited 4× · PMID 34112154 · DOI 10.1186/s12912-021-00617-z

Verify or expand the search:

Other recruiting trials for Patient Empowerment

Currently open trials in the same condition.

Other University of Turku trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04160650.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing