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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02751723
Acronym
APM-Project
Enrollment
500
Registered
2016-04-26
Start date
2014-09-30
Completion date
2019-10-31
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Disease, Palliative Therapy

Keywords

cancer disease, palliative care, palliative therapy, cancer, patient´s needs, patient care, disease burden

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.

Interventions

Sponsors

Florian Lordick, MD
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline Patient´s answers regarding symptom burden at 12 months12 months after enrollment

Secondary

MeasureTime frame
Change from Baseline physician´s report at 12 months12 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 6 months6 months after enrollment
Change from Baseline physician´s report at 6 months6 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 3 months3 months after enrollment
Change from Baseline physician´s report at 3 months3 months after enrollment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026