C51-C58 C43-C44 C15-C26
Conditions
Interventions
Group 1: 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.
Group 2:
Sponsors
Sächsische Krebsgesellschaft e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalization rate (percentage of patients with a 1+ additional hospitalisation compared to standard number of hospitalizations during 12 months) in intervention/control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactRalf Porzig
Sächsische Krebsgesellschaft e.V.
Outcome results
None listed