Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories

NCT ID: NCT03281447

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-26
• Study Completion Date: 2018-12-31

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.

Detailed Description

The primary hypothesis in this study is:

Nurse navigation, as a specific, defined concept of coherent help through cancer trajectories, will prove superior to current care coordination with regard to patients' self-evaluated self-efficacy for cancer from inclusion to one week after receipt of information about treatment end or not later than one year after inclusion.

Allocation The randomization will be stratified by age and gender. The rational is that age and gender is differently associated with benefit by a given care.

Data collection Participants fill in questionnaires at four measurements, and supplements to sociodemographic information as well as information for an economic evaluation is collected from provider side.

The questionnaires for participants are available in paper and electronically, and participants are allowed to discuss the individual questions with a person whom they trust before filling in their answers. If a participant is blind or dyslexic and has no one to help them fill in the questionnaires, a trained study nurse will read out loud the questions and fill in the participant's answers, and eventually in this process, listen to the participant's pros and cons, acknowledge that they are heard, ask for an answer and read out loud the question again. All data are stored in Research Electronic Data Capture (RedCap).

Blinding The trial is not blinded but all participants are told, there is no favorite group. The statistician is blinded to randomization group and this blinding will be unveiled after the data is analyzed.

Statistics Data are analyzed following the modified intention-to-treat principle, which is carried out by a senior statistician in close collaboration with the research group. Usual descriptive statistics will be used to summarize baseline and subject characteristics. The analyses of the primary endpoint, i.e. change in self-evaluated self-efficacy for cancer from inclusion (measurement 1) to end of treatment (measurement 3), and the secondary outcomes are done using analysis of covariance of the measure at measurement 3 with randomization group as a factor and measure at measurement 1 as covariate. In secondary analyses for all endpoints (measurement 1-4), the change over time will be investigated by mixed effects repeated measures analysis with randomization group as factor and random effects for subjects. These analyses are repeated within the subgroup of all cancer patients and the subgroup of cancer patients treated with curative aim. In the subgroup analyses, the influence of relevant subject-level confounders such as age, disease-stage, treatment, etc. will be explored, and appropriate adjustment will be performed. An economic evaluation will be performed for each randomized group and compared.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nurse navigation

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

Group Type: EXPERIMENTAL

Nurse navigation

Intervention Type: OTHER

Current care coordination

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

Group Type: ACTIVE_COMPARATOR

Current care coordination

Intervention Type: OTHER

Interventions

Nurse navigation

Intervention Type: OTHER

Current care coordination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

Slagelse Hospital

OTHER

Sponsor Role: collaborator

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Region Zealand

OTHER

Sponsor Role: collaborator

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Odense Patient Data Explorative Network

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marianne K. Thygesen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lise Fillion, PhD

Role: STUDY_CHAIR

Nursing Faculty, Laval University

Jens Søndergaard, PhD

Role: STUDY_CHAIR

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

Marianne K Thygesen, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Niels Qvist, DMSc

Role: STUDY_DIRECTOR

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

Other Identifiers

2008-58-0035

Identifier Type: OTHER

Identifier Source: secondary_id

020-2016-NQ

Identifier Type: -

Identifier Source: org_study_id