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Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories (NaviCan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281447
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
University of Southern Denmark
Laval University
Slagelse Hospital
Region of Southern Denmark
Region Zealand
Danish Cancer Society
Odense Patient Data Explorative Network
Information provided by (Responsible Party):
Marianne K. Thygesen, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Self Efficacy Continuity of Care Quality of Life Colorectal Neoplasms Case Management Other: Nurse navigation Other: Current care coordination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: NaviCan. Navigation and Support to Cancer Patients - A Randomized Controlled Trial.
Actual Study Start Date : February 26, 2016
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : December 31, 2018

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.
Other: Nurse navigation
Active Comparator: Current care coordination
Department-specific coordination and answers to questions from a patient-centred viewpoint.
Other: Current care coordination



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. Continuity of care [ Time Frame: Change in "Continuity of care" from inclusion to three days before treatment start. ]
    Qualitatively validated questions answered by participants

  8. Continuity of care [ Time Frame: Change in "Continuity of care" from inclusion to six weeks after measurement 3. ]
    Qualitatively validated questions answered by participants

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281447


Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Laval University
Slagelse Hospital
Region of Southern Denmark
Region Zealand
Danish Cancer Society
Odense Patient Data Explorative Network
Investigators
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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
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Responsible Party: Marianne K. Thygesen, Associate professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03281447    
Other Study ID Numbers: 020-2016-NQ
2008-58-0035 ( Other Identifier: the Danish Data Protection Agency )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marianne K. Thygesen, Odense University Hospital:
Nurse navigation
Family
Self Efficacy
Needs assessment
Quality of Life
Colorectal Neoplasms
Case Management
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases