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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach

1 country

21 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.1 years study duration

Study Start

First participant enrolled

September 1, 2014

Completed

1.6 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed

12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed

Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

5.1 years

First QC Date

April 14, 2016

Last Update Submit

March 6, 2019

Conditions

Cancer Disease, Palliative Therapy

Keywords

cancer diseasepalliative carepalliative therapycancerpatient´s needspatient caredisease burden

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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