Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Disease, Palliative Therapy
- Sponsor
- Florian Lordick, MD
- Enrollment
- 500
- Locations
- 21
- Primary Endpoint
- Change from Baseline Patient´s answers regarding symptom burden at 12 months
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Florian Lordick, MD
Prof. Dr. med. (MD, PhD)
University of Leipzig
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from Baseline Patient´s answers regarding symptom burden at 12 months
Time Frame: 12 months after enrollment
Secondary Outcomes
- 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)
- Change from Baseline physician´s report at 6 months(6 months after enrollment)
- 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)