Self EfficacyNaviCanNCT03281447
Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories
A study testing Nurse navigation and Current care coordination in people with Self Efficacy and Continuity of Care, run by Odense University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Efficacy, Continuity of Care, Quality of Life
- What is being tested?
- Nurse navigation and Current care coordination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Nurse navigation, Current care coordination
- Keywords
- Nurse navigation, Family, Self Efficacy, Needs assessment, Quality of Life, Colorectal Neoplasms, Case Management
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse navigationOther
Current care coordinationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nurse navigation |
| Current care coordination | Active comparator | Department-specific coordination and answers to questions from a patient-centred viewpoint. Receives: Other: Current care coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self evaluated Self Efficacy for Cancer
Cancer Behaviour Inventory - Brief
Measured: 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
Cancer Behaviour Inventory - Brief
Measured: Change in "Cancer Behaviour Inventory - Brief" from inclusion to three days before treatment start.
Self evaluated Self Efficacy for Cancer
Cancer Behaviour Inventory - Brief
Measured: Change in "Cancer Behaviour Inventory - Brief" from inclusion to six weeks after measurement 3.
Self evaluated Self Efficacy for Cancer
Cancer Behaviour Inventory - Brief
Measured: 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
Cancer Behaviour Inventory - Brief
Measured: Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to six weeks after measurement 3.
Self evaluated Self Efficacy for Cancer
Cancer Behaviour Inventory - Brief
Measured: 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
Qualitatively validated questions answered by participants
Measured: 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
Qualitatively validated questions answered by participants
Measured: Change in "Continuity of care" from inclusion to three days before treatment start.
Continuity of care
Qualitatively validated questions answered by participants
Measured: Change in "Continuity of care" from inclusion to six weeks after measurement 3.
Continuity of care
Qualitatively validated questions answered by participants
Measured: 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
Qualitatively validated questions answered by participants
Measured: Change in "Continuity of care" from three days before treatment start to six weeks after measurement 3.
Continuity of care
Qualitatively validated questions
Measured: 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
Patients experienced needs and degree of fulfilled support
Measured: 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
Patients experienced needs and degree of fulfilled support
Measured: Change in "Unmet needs" from three days before treatment start to six weeks after measurement 3.
Unmet needs
Patients experienced needs and degree of fulfilled support
Measured: 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
European Organisation for Research and Treatment of Cancer Quality of life questionnaire with 30 questions (EORCT QLQ-c30).
Measured: Change in "Health-related Quality of Life" from three days before treatment start to six weeks after measurement 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start26 Feb 2016
- Primary completion23 Oct 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Laval University, Slagelse Hospital, Region of Southern Denmark, Region Zealand, Danish Cancer Society, Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Marianne K. Thygesen, Odense University Hospital
- Investigators
- Lise Fillion, PhD, Study chair, Nursing Faculty, Laval UniversityJens Søndergaard, PhD, Study chair, Research Unit of General Practice, Faculty of Health Sciences, University of Southern DenmarkMarianne K Thygesen, PhD, Principal investigator, Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern DenmarkNiels Qvist, DMSc, Study director, Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281447
- Sponsor's protocol ID
- 020-2016-NQ
- Other IDs
- 2008-58-0035
- Acronym
- NaviCan
- Status last verified
- Apr 2019
- First submitted
- 11 Sep 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NaviCan. Navigation and Support to Cancer Patients - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03281447
- Acronym / sponsor ID
- NaviCan / 020-2016-NQ
- Keywords
- Nurse navigation, Family, Self Efficacy, Needs assessment, Quality of Life, Colorectal Neoplasms, Case Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Laval University, Slagelse Hospital, Region of Southern Denmark, Region Zealand, Danish Cancer Society, Odense Patient Data Explorative Network
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse navigation | Experimental | Other: Nurse navigationCoherent navigation and support from a family-centred viewpoint throughout the cancer trajectory, despite the individual patient's affiliation to any department. |
| Current care coordination | Active comparator | Other: Current care coordinationDepartment-specific coordination and answers to questions from a patient-centred viewpoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse navigation | Other | Nurse navigation |
| Current care coordination | Other | Current care coordination |
Primary outcome
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
15 secondary outcomes
Self evaluated Self Efficacy for Cancer
Time frame: 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.
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.
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.
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.
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.
Continuity of care
Time frame: 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.
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.
Continuity of care
Time frame: 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.
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.
Unmet needs
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Fillion, PhD study chair
Nursing Faculty, Laval University
Jens Søndergaard, PhD study chair
Research Unit of General Practice, Faculty of Health Sciences, University of Southern Denmark
Marianne K Thygesen, PhD principal investigator
Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Nurse navigation and Current care coordination in people with Self Efficacy and Continuity of Care, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.