Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease

Study Overview
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Brief Summary
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The aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by various validated questionnaires. The data obtained by these questionnaires are collected together with information obtained by the treating physicians at four time points during the study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative project offers the chance to identify medical services deficits and risk circumstances for the burden of treatments in an oncology-palliative setting and to optimize the quality of patient care.

Official Title
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Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease

Conditions
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Cancer Disease, Palliative Therapy

Intervention / Treatment
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* Other: validated questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incurable cancer disease: ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer signed and dated Inform Consent Form Age ≥ 18 years Exclusion Criteria: Patient is not able to understand and to answer questions Patient is in a critical health situation and is directly threatened due to cancer disease or the resulting complications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lung cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| malignant melanoma<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| cancer of the hepatobiliary system<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| head and neck cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| breast cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| ovarian carcinoma<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| pancreatic cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| stomach cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| oesophageal cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |
| colorectal cancer<br>validated questionnaires | Other: validated questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Patient´s answers regarding symptom burden at 12 months |  | 12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline physician´s report at 12 months |  | 12 months after enrollment | 
| Change from Baseline Patient´s answers regarding symptom burden at 6 months |  | 6 months after enrollment | 
| Change from Baseline physician´s report at 6 months |  | 6 months after enrollment | 
| Change from Baseline Patient´s answers regarding symptom burden at 3 months |  | 3 months after enrollment | 
| Change from Baseline physician´s report at 3 months |  | 3 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer disease, palliative care, palliative therapy, cancer, patient´s needs, patient care, disease burden