Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories

NCT03281447 | Completed

• 2 other identifiers: 020-2016-NQ2008-58-0035
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Nurse navigation; Family; Self Efficacy; Needs assessment; Quality of Life; Colorectal Neoplasms; Case Management

Outcome Measures

Primary Outcomes (1)

• Self evaluated Self Efficacy for Cancer

  Cancer Behaviour Inventory - Brief

  Change in "Cancer Behaviour Inventory - Brief" from inclusion to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.

Secondary Outcomes (15)

• Self evaluated Self Efficacy for Cancer

  Change in "Cancer Behaviour Inventory - Brief" from inclusion to three days before treatment start.

• Self evaluated Self Efficacy for Cancer

  Change in "Cancer Behaviour Inventory - Brief" from inclusion to six weeks after measurement 3.

• Self evaluated Self Efficacy for Cancer

  Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.

• Self evaluated Self Efficacy for Cancer

  Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to six weeks after measurement 3.

• Self evaluated Self Efficacy for Cancer

  Change in "Cancer Behaviour Inventory - Brief" from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.

Study Arms (2)

Nurse navigation

EXPERIMENTAL

Coherent navigation and support from a family-centred viewpoint throughout the cancer trajectory, despite the individual patient's affiliation to any department.

Other: Nurse navigation

Current care coordination

ACTIVE COMPARATOR

Department-specific coordination and answers to questions from a patient-centred viewpoint.

Other: Current care coordination

Interventions

Nurse navigation OTHER

Nurse navigation

Current care coordination OTHER

Current care coordination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lesions suspected for cancer in the colon or rectum recognized through colonoscopy or sigmoidoscopy found at scopy centres in Odense, Nyborg, Svendborg or Slagelse, all in Denmark
• Can speak and understand Danish.

You may not qualify if:

• Life-threatening disease: score 4 in the American Society of Anaesthesiologists status classification system.
• Dementia ( Diagnosed or in a diagnostic phase).
• Severe psychiatric disease ( Diagnosed or in a diagnostic phase).
• Mentally retarded ( Diagnosed or in a diagnostic phase).

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Laval University: collaborator
• Slagelse Hospital: collaborator
• Region of Southern Denmark: collaborator
• Region Zealand: collaborator
• Danish Cancer Society: collaborator
• Odense Patient Data Explorative Network: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lise Fillion, PhD

  Nursing Faculty, Laval University

  STUDY CHAIR

• Jens Søndergaard, PhD

  Research Unit of General Practice, Faculty of Health Sciences, University of Southern Denmark

  STUDY CHAIR

• Marianne K Thygesen, PhD

  Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Niels Qvist, DMSc

  Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: February 26, 2016
• Primary Completion: October 23, 2017
• Study Completion: December 31, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share