- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281447
Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories (NaviCan)
NaviCan. Navigation and Support to Cancer Patients - A Randomized Controlled Trial.
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nurse navigation
Coherent navigation and support from a family-centred viewpoint throughout the cancer trajectory, despite the individual patient's affiliation to any department.
|
|
Active Comparator: Current care coordination
Department-specific coordination and answers to questions from a patient-centred viewpoint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self evaluated Self Efficacy for Cancer
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self evaluated Self Efficacy for Cancer
Time Frame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to three days before treatment start.
|
Cancer Behaviour Inventory - Brief
|
Change in "Cancer Behaviour Inventory - Brief" from inclusion to three days before treatment start.
|
Self evaluated Self Efficacy for Cancer
Time Frame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to six weeks after measurement 3.
|
Cancer Behaviour Inventory - Brief
|
Change in "Cancer Behaviour Inventory - Brief" from inclusion to six weeks after measurement 3.
|
Self evaluated Self Efficacy for Cancer
Time Frame: 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.
|
Cancer Behaviour Inventory - Brief
|
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
Time Frame: Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to six weeks after measurement 3.
|
Cancer Behaviour Inventory - Brief
|
Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to six weeks after measurement 3.
|
Self evaluated Self Efficacy for Cancer
Time Frame: 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.
|
Cancer Behaviour Inventory - Brief
|
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.
|
Continuity of care
Time Frame: 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.
|
Qualitatively validated questions answered by participants
|
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.
|
Continuity of care
Time Frame: Change in "Continuity of care" from inclusion to three days before treatment start.
|
Qualitatively validated questions answered by participants
|
Change in "Continuity of care" from inclusion to three days before treatment start.
|
Continuity of care
Time Frame: Change in "Continuity of care" from inclusion to six weeks after measurement 3.
|
Qualitatively validated questions answered by participants
|
Change in "Continuity of care" from inclusion to six weeks after measurement 3.
|
Continuity of care
Time Frame: 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.
|
Qualitatively validated questions answered by participants
|
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.
|
Continuity of care
Time Frame: Change in "Continuity of care" from three days before treatment start to six weeks after measurement 3.
|
Qualitatively validated questions answered by participants
|
Change in "Continuity of care" from three days before treatment start to six weeks after measurement 3.
|
Continuity of care
Time Frame: 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.
|
Qualitatively validated questions
|
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.
|
Unmet needs
Time Frame: 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.
|
Patients experienced needs and degree of fulfilled support
|
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.
|
Unmet needs
Time Frame: Change in "Unmet needs" from three days before treatment start to six weeks after measurement 3.
|
Patients experienced needs and degree of fulfilled support
|
Change in "Unmet needs" from three days before treatment start to six weeks after measurement 3.
|
Unmet needs
Time Frame: 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.
|
Patients experienced needs and degree of fulfilled support
|
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.
|
Health-related Quality of Life
Time Frame: Change in "Health-related Quality of Life" from three days before treatment start to six weeks after measurement 3.
|
European Organisation for Research and Treatment of Cancer Quality of life questionnaire with 30 questions (EORCT QLQ-c30).
|
Change in "Health-related Quality of Life" from three days before treatment start to six weeks after measurement 3.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: 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
- Principal Investigator: Marianne K Thygesen, PhD, Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark
- Study Director: Niels Qvist, DMSc, Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 020-2016-NQ
- 2008-58-0035 (Other Identifier: the Danish Data Protection Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
Clinical Trials on Nurse navigation
-
Wake Forest University Health SciencesCompletedGastrointestinal CancerUnited States
-
Danish Cancer SocietyRigshospitalet, Denmark; TRYG Foundation; Center for Kræft og SundhedCompletedDepression | Anxiety | Health Behavior | Adverse EffectsDenmark
-
Danish Cancer SocietyRigshospitalet, Denmark; Copenhagen University Hospital at HerlevCompleted
-
Kilis 7 Aralik UniversityCompleted
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
-
Adonis Hijaz, MDRecruiting
-
University Hospital, ToulouseUnknownHematologic NeoplasmsFrance
-
Ondokuz Mayıs UniversityCompleted
-
Tufts Medical CenterThe Leukemia and Lymphoma SocietyActive, not recruitingCancer | Financial Stress | SurvivorshipUnited States