Trial document




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  DRKS00013199

Trial Description

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Title

A randomized-controlled multicentre evaluation of an Oncology Nurse Navigator on hospitalization, health outcomes, health care utilization and health care costs

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Trial Acronym

Nurse Navigators

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URL of the Trial

http://www.onkolotse.de/aktuelles.html

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Brief Summary in Lay Language

Despite the growing interest among health policy makers, hesitation remains to a widespread adoption of nurse navigation services for German cancer patients or for providing reimbursement due to a lack of economic information related to establishing and sustaining these programs, as well as the economic value. This issue is recognized as an important unmet need from SKG and a few pioneering hospitals and practices which already have oncology nurse navigators. Until now, they have been funded out of care budgets for medical care and their sustainability is uncertain.
Empirical evidence on the role of patient navigation programs supports that they are recognized as a cost effective method to improve health outcomes and quality of life. Oncology nurse navigation programs can be easily integrated in physicians’ routine and thus can be effective outside the framework of clinical research. The usefulness of the navigation program has also been reported in a patient and caregiver survey by SKG where acceptance of the nurse navigators, reduction on burden placed on physicians and nurses and patient satisfaction was investigated.
The aim of this study is to evaluate the effect of nurse navigation on patients with cancer to provide payers in Germany with an evidenced-base for decision-making. The increase of cancer burden is amongst other things being propelled by demographic changes. Therefore this study includes different entities and stages of cancer in order to meet the need of cancer patients in general. 340 patients can take part in this study which will be conducted at Gynäkologisches Krebszentrum und Hautkrebszentrum at DRK Krankenhaus Chemnitz-Rabenstein, Darmkrebszentrum at Ev. Diakonissenkrankenhaus Leipzig, Darmzentrum at Elblandklinikum Stollberg and Klinik für Gynäkologie am Klinikum St. Georg in Leipzig. The primary aim of the study is to assess the effectiveness of the “Onkolotse” in improving the health care provision received by patients, but also the impact of this program on relatives and care providers. The secondary objective of the presented study is to evaluate changes in the psychological burden experienced by the patients.

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Brief Summary in Scientific Language

The primary objective of the Oncology Nurse Navigator Program is to evaluate changes in the hospitalizations of patients with cancer. The Oncology Nurse Navigator Program will be evaluated using a prospective randomized longitudinal and cross-sectional multi-center design. The study population of this evaluation includes oncology patients (melanoma, stomach cancer, pancreatic cancer, colon cancer and gynecological cancer) who have had at least one stationary visit to one of the study centers, their relatives, inpatient doctors, outpatient doctors and oncology nurses. The recruitment of patients will begin in November 2017. Patients will be recruited over a period of 6-9 months. The intervention (Oncology Nurse Navigator Program), which the Intervention Group (IG) will receive, will last 12 months. The intervention/exposure which the patients in the IG will receive is the Oncology Nurse Navigation Program. The control group will receive standard care with no further specifications. Primary endpoint: hospitalization rate (percentage of patients with a 1+ additional hospitalisation compared to standard number of hospitalizations during 12 months) in intervention/control group. Secondary endpoints: psychological burden (HADS-D), workflow, health care costs, quality of life and health literacy with differences between intervention and control group and within the intervention group to come to the fore. The analysis of the primary endpoint, the difference between intervention and control group concerning the hospitalization rate, will be carried out by a chi-square-test with a significance level of 5 %. This will be verified by a generalized linear model which will take more factors of influence into account. To determine a relevant reduction of 50% of hospitalizations on average (from 25% of patients with a 1+ additional hospitalisation compared to standard number of hospitalizations to 12,5 % of patients in the intervention group) with a significance level of α ≤ 0.05 (chi-square-test, normal approximation, PROC POWER SAS 9.4) and a power of 80%, and an estimated dropout rate of 10%, a minimum gross sample size of 169 patients per group is pursued. Patients are from one geographic area, which limits the generalizability of the results. Some items are self-reported and therefore may not be representing the actual reality (for example utilization of health care services). Bias types and missing data are considered in statistical analyses and interpretation of results.

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Organizational Data

  •   DRKS00013199
  •   2017/10/27
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  •   yes
  •   Approved
  •   EK-BR-51/17-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   C51-C58 -  Malignant neoplasms of female genital organs
  •   C43-C44 -  Melanoma and other malignant neoplasms of skin
  •   C15-C26 -  Malignant neoplasms of digestive organs
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Interventions/Observational Groups

  •   Intervention group (IG, 170 patients) = Standard up to date medical treatment and care according to guidelines + support by Nurse navigators (Onkolotsen) over a period of 12 months.
  •   Control group (KG, 170 patients) = Standard up to date medical treatment and care according to guidelines without further support by Nurse navigators (Onkolotsen).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Hospitalization rate (percentage of patients with a 1+ additional hospitalisation compared to standard number of hospitalizations during 12 months) in intervention/control group.

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Secondary Outcome

The secondary objective of the presented study is to evaluate changes in the psychological burden experienced by the patients from baseline and between intervention and control group using the Hospital Anxiety and Depression Scale (HADS-D).
The hypothesis is: The psychological burden of patients with cancer will be lowered through the Cancer Nurse Navigator Program. Patients in the intervention group will show lower levels of anxiety and distress (HADS-D) compared to baseline (t1) and compared to patients in the control group at t2 and t3. Further secondary objectives are the analysis and comparison of the health care cost development in the intervention and control group as well as changes in several variables (e.g. quality of life) based on questionnaires.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2017/11/01
  •   340
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patient has an in-patient stay at one of the five study centers.
Patient has a diagnosis of breast cancer, stomach cancer, intestinal cancer or rectum cancer or melanoma.
Patient has a cancer which can be classified into one of the following UICC TNM groups
o 0 (tis, N0, M0)
o Ia (T1, N0, M0)
o Ib (T2, N0, M0)
o IIa (T3, N0, M0)
o IIb (T4, N0, M0)
o IIIa (every T, N1, M0)
o IIIb (every T, N2, M0)
o IV (every T, every N, M1)
or has a tumor recurrence or has metastases (for melanoma also metastases other than skin metastases).
Patient is between the age of 18 and older at the time of inclusion in this study.
Patient is according to their doctors capable to participate in the program/ to receive the intervention.
Patient has signed the informed consent form. Patient participates on a voluntary basis.

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Exclusion Criteria

Patient is in a stationary institution (for example palliative care, hospice) for terminal treatment.
Patient has severe comorbidities whose treatment are paramount.
Participation in a disease management program.
Pregnancy/Breast feeding.

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Addresses

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    • Sächsische Krebsgesellschaft e.V.
    • Mr.  Dr.  Ralf  Porzig 
    • Schlobigplatz 23
    • 08056  Zwickau
    • Germany
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    • Sächsische Krebsgesellschaft e.V.
    • Mr.  Dr.  Ralf  Porzig 
    • Schlobigplatz 23
    • 08056  Zwickau
    • Germany
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    • Sächsische Krebsgesellschaft e.V.
    • Mr.  Dr.  Ralf  Porzig 
    • Schlobigplatz 23
    • 08056  Zwickau
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebsstiftung
    • Kuno-Fischer-Straße 8
    • 14057  Berlin
    • Germany
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    • Gewinnsparen der Sparda Bank eG
    • Storkower Str. 101 A
    • 10407  Berlin
    • Germany
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    • MSD GmbH
    • Lindenpl. 1
    • 85540  Haar
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.