CClinicalTrials.gg
Status unknownNCT02751723APM-ProjectUpdated Mar 7, 2019

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

An observational study in Cancer Disease, Palliative Therapy, sponsored by Florian Lordick, MD. Status unknown at 21 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by Florian Lordick, MD · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer Disease, Palliative Therapy

Keywords

  • cancer disease
  • palliative care
  • palliative therapy
  • cancer
  • patient´s needs
  • patient care
  • disease burden
03

In context

Lead sponsor

This is the only study on the registry with Florian Lordick, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with newly diagnosed incurable cancer disease before start of any tumor therapy

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • lung cancer

    validated questionnaires

    Other: validated questionnaires

  • malignant melanoma

    validated questionnaires

    Other: validated questionnaires

  • cancer of the hepatobiliary system

    validated questionnaires

    Other: validated questionnaires

  • head and neck cancer

    validated questionnaires

    Other: validated questionnaires

  • breast cancer

    validated questionnaires

    Other: validated questionnaires

  • ovarian carcinoma

    validated questionnaires

    Other: validated questionnaires

  • pancreatic cancer

    validated questionnaires

    Other: validated questionnaires

  • stomach cancer

    validated questionnaires

    Other: validated questionnaires

  • oesophageal cancer

    validated questionnaires

    Other: validated questionnaires

  • colorectal cancer

    validated questionnaires

    Other: validated questionnaires

Interventions

  • Othervalidated questionnaires
06

What researchers measure

Primary outcomes

  1. Change from Baseline Patient´s answers regarding symptom burden at 12 months

    Time frame: 12 months after enrollment

Secondary outcomes

  1. Change from Baseline physician´s report at 12 months

    Time frame: 12 months after enrollment

  2. Change from Baseline Patient´s answers regarding symptom burden at 6 months

    Time frame: 6 months after enrollment

  3. Change from Baseline physician´s report at 6 months

    Time frame: 6 months after enrollment

  4. Change from Baseline Patient´s answers regarding symptom burden at 3 months

    Time frame: 3 months after enrollment

  5. Change from Baseline physician´s report at 3 months

    Time frame: 3 months after enrollment

07

Study locations

21 sites
  • UCCL, University of Leipzig
    Leipzig, Saxony 04103, Germany
  • Municipal Hospital Braunschweig
    Braunschweig, Germany
  • Internal medicine practice
    Burgwedel, Germany
  • Municipal Hospital Essen-Mitte
    Essen, Germany
  • University of Essen
    Essen, Germany
  • University of Göttingen
    Göttingen, Germany
  • University of Hamburg-Eppendorf
    Hamburg, Germany
  • Medical University Hanover
    Hanover, Germany
  • Clinic for Thoraric Diseases (Thoraxklinik)
    Heidelberg, Germany
  • Municipal Hospital Karlsruhe
    Karlsruhe, Germany
  • University of Leipzig, ENT
    Leipzig, Germany
  • Hospital Leverkusen
    Leverkusen, Germany
  • Municipal Hospital Magdeburg
    Magdeburg, Germany
  • University of Mainz
    Mainz, Germany
  • Maria Hilf Clinic
    Mönchengladbach, Germany
  • Radiotherapy practice
    Recklinghausen, Germany
  • University of Regensburg
    Regensburg, Germany
  • Hospital Südstadt Rostock
    Rostock, Germany
  • Immanuel Hospital Rüdersdorf
    Rüdersdorf, Germany
  • Hospital Traunstein
    Traunstein, Germany
  • Comprehensive Cancer Centre Main-Franken
    Würzburg, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02751723
Lead sponsor
Florian Lordick, MD
Responsible party
Florian Lordick, MD (Prof. Dr. med. (MD, PhD), University of Leipzig) — Sponsor-investigator
First posted
Apr 26, 2016
Start date
Sep 2014
Primary completion
Oct 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Mar 7, 2019

Study contacts

Florian Lordick, Prof. Dr.
study chair · University of Leipzig
Bend Alt-Epping, PD Dr.
study chair · University of Göttingen
Anja Mehnert, Prof. Dr.
study chair · University of Leipzig
Birgitt van Oorschot, Prof. Dr.
study chair · Comprehensive Cancer Centre Main-Franken, Würzburg
Michael Thomas, Prof. Dr.
study chair · Heidelberg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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