Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories

NCT03281447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-04-04

No results posted yet for this study

Summary

In western countries, the number of cancer survivors increases, and current cancer care seems insufficient with both patients' experiences of lack of help in transitions and up to 60 % of the patients having psychological problems after treatment. Further, Denmark shall have new hospitals, where researchers and healthcare professionals are expected to merge tasks and reach a higher patient experienced quality of care, without additional costs, so a better way to provide cancer care, which benefits the patients and supports the ideas within the new hospitals in Denmark, is needed.

In a randomized controlled trial, the organizational structure of the healthcare system is challenged and the impact of a coherent nurse navigation practice compared to the currently existing department-specific care coordination is tested. The primary data are changes in patients' self-reported cancer-related self-efficacy from inclusion till one week after receipt of the information that they have reached the end of treatment, or in case of prolonged treatment, till not later than one year after inclusion.

Patients can participate if they are 18 years of age or older, speak and understand Danish, and have a proven lesion suspected of cancer in the colon or rectum after colonoscopy or sigmoidoscopy at the Danish endoscopy centers at Odense University Hospital (the cities: Nyborg, Svendborg and Odense) or at Slagelse Hospital. Furthermore, participants must not be mentally retarded, they must not suffer from a constant life-threatening disease, and they must not suffer from, or be in the diagnostic phase of, dementia or severe psychiatric disease.

Participants are allocated to support from nurse navigation or to current care coordination, and fill in four questionnaires during their cancer trajectory: 1) At inclusion, 2) Three days before treatment start, 3) One week after receipt of information about treatment end or not later than one year after inclusion, and 4) Six weeks after measure point 3. Data is analyzed using suitable statistical models.

With positive results, participants in nurse navigation are better helped during their cancer trajectory and have a better psychological start on the rest of their lives after cancer treatment. Focus will be on colon and rectum cancer care, but the results will be transferable to similar settings. Furthermore, positive results will support changes in the onset of rehabilitation initiatives.

Conditions

  • Self Efficacy
  • Continuity of Care
  • Quality of Life
  • Colorectal Neoplasms
  • Case Management

Interventions

OTHER

Nurse navigation

OTHER

Current care coordination

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER
  • Laval University

    collaborator OTHER
  • Slagelse Hospital

    collaborator OTHER
  • Region of Southern Denmark

    collaborator OTHER
  • Region Zealand

    collaborator OTHER
  • Danish Cancer Society

    collaborator OTHER
  • Odense Patient Data Explorative Network

    collaborator OTHER
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lise Fillion, PhD · Nursing Faculty, Laval University

  • Jens Søndergaard, PhD · Research Unit of General Practice, Faculty of Health Sciences, University of Southern Denmark

  • Marianne K Thygesen, PhD · Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark

  • Niels Qvist, DMSc · Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-26
Primary Completion
2017-10-23
Completion
2018-12-31

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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 NCT03281447 on ClinicalTrials.gov