Clinical trial NCT03281447: Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories
Official title: NaviCan. Navigation and Support to Cancer Patients - A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Laval University
name: Slagelse Hospital
name: Region of Southern Denmark
name: Region Zealand
name: Danish Cancer Society
name: Odense Patient Data Explorative Network
First posted: 2017-09-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Self evaluated Self Efficacy for Cancer
timeFrame: 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:
measure: Self evaluated Self Efficacy for Cancer
timeFrame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to three days before treatment start.
measure: Self evaluated Self Efficacy for Cancer
timeFrame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to six weeks after measurement 3.
measure: Self evaluated Self Efficacy for Cancer
timeFrame: 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.
measure: Self evaluated Self Efficacy for Cancer
timeFrame: Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to six weeks after measurement 3.
measure: Self evaluated Self Efficacy for Cancer
timeFrame: 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.
measure: Continuity of care
timeFrame: Change in "Continuity of care" from inclusion to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.
measure: Continuity of care
timeFrame: Change in "Continuity of care" from inclusion to three days before treatment start.
measure: Continuity of care
timeFrame: Change in "Continuity of care" from inclusion to six weeks after measurement 3.
measure: Continuity of care
timeFrame: Change in "Continuity of care" 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.
measure: Continuity of care
timeFrame: Change in "Continuity of care" from three days before treatment start to six weeks after measurement 3.
measure: Continuity of care
timeFrame: Change in "Continuity of care" 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.
measure: Unmet needs
timeFrame: Change in "Unmet needs" 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.
measure: Unmet needs
timeFrame: Change in "Unmet needs" from three days before treatment start to six weeks after measurement 3.
measure: Unmet needs
timeFrame: 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.
measure: Health-related Quality of Life
timeFrame: Change in "Health-related Quality of Life" from three days before treatment start to six weeks after measurement 3.
Other outcomes:
Locations:
Study officials:
affiliation: Nursing Faculty, Laval University
name: Lise Fillion, PhD
role: STUDY_CHAIR
affiliation: Research Unit of General Practice, Faculty of Health Sciences, University of Southern Denmark
name: Jens Søndergaard, PhD
role: STUDY_CHAIR
affiliation: Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark
name: Marianne K Thygesen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark
name: Niels Qvist, DMSc
role: STUDY_DIRECTOR
References: