Screening versus multidimensional assessment of symptoms and psychosocial burden of cancer patients at the diagnosis of incurability
Organizational Data
- DRKS-ID:
- DRKS00017774
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-01-07
- Last update in DRKS:
- 2020-01-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
People who are terminally ill with cancer can benefit from a palliative care concept early on. Palliative care has a positive impact on patients' quality of life and their social environment, and helps them to realize their preferred treatment. In addition, Palliative Care contributes to avoiding maltreatment and overtreatment - and therefore avoids unnecessary costs. However, it is unclear how to determine the symptoms and needs that demand for palliative care. Surprisingly, doctors estimated that about 16 percent of all patients have palliative support needs. The aim of the project is to clarify which strategy of assessment is best for identifying symptoms and needs, so that incurably ill cancer patients can benefit most. To do this, the scientists compare two different strategies: a less complex screening (i.e. less time-consuming) and a multi-dimensional assessment (more comprehensive and time-consuming). They examine the influence of the two methods on the quality of life of patients. For this purpose, they determine the duration and frequency of hospital stays and the involvement of palliative care or psychosocial support. In addition, they test which method more reliably determines the patient's palliative care needs and whether the two detection methods differ from previous data. In case of success, a substantial contribution to the question will be found what an improved, appropriate, timely, structured palliative care can provide for incurable cancer patients. In addition, important arguments might be gained to involve specialized palliative care at an early stage, thus hopefully improving the care of people with cancer.
Brief summary in scientific language
Comparison of strategies for recording symptoms and burden for on-demand palliative care treatment (including psychosocial support), instead of previous prognosis-oriented early integration concepts for cancer patients
Health condition or problem studied
- Free text:
- patients with an incurable cancer disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- screening, Patient will be asked short questionnaires (NCCN Distress Thermometer and IPOS) every 3-6 weeks
- Arm 2:
- multidimensional assessment
Endpoints
- Primary outcome:
- Quality of life after 6 months in both intervention arms using FACT-G, PHQ4, SCNS-34, NCCN distress thermometer.
- Secondary outcome:
- - number of days spent in hospital and frequency of inclusion of emergency, palliative care and psychosocial care structures; Comparison of positive and negative screened patients with the actual inclusion of palliative care - Comparison of the two intervention arms, also comparing them with a "not-included 'historical'" control group (usual care) - Descriptive analysis of symptoms and stress in both intervention arms
Study Design
- Purpose:
- Screening
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center UMG Göttingen
- Medical center Universitätsmedizin Mainz Mainz
- Medical center Immanuel Poliklinik Rüdersdorf Rüdersdorf
- Medical center Städtisches Klinikum Brandenburg Brandenburg
- Medical center Universitätsklinikum Jena Jena
- Medical center Universitätskrebszentrum Leipzig Leipzig
- Medical center Charite Berlin Berlin
- Medical center Akademisches Lehrkrankenhaus der Universitätsklinik an der RWTH Aachen Mönchengladbach
- Medical center Universitätsklinikum Tübingen Tübingen
- Medical center Klinikum Stuttgart Katharinenhospital Stuttgart
- Medical center Städtisches Klinikum Braunschweig Braunschweig
- Medical center Kliniken Essen-Mitte Essen
- Doctor's practice Burgwedel
- Medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
- Medical center Klinikum Magdeburg Magdeburg
- Medical center Klinikum Traunstein Traunstein
- Doctor's practice Recklinghausen
- Medical center Universitätsklinikum Würzburg Würzburg
- Medical center St. Josef Hospital Wiesbaden Wiesbaden
- Medical center Klinikum Südstadt - Rostock Rostock
- Medical center Uniklinikum Münster Münster
- Medical center Universitätsklinikum Leverkusen Leverkusen
- Medical center Klinikum Karlsruhe Karlsruhe
- Medical center Universitätsfrauenklinik Regensburg Regensburg
- Medical center Uniklinik Regensburg Regensburg
- Medical center Krankenhaus Nordwest Frankfurt a.M.
- Medical center Universitätsfrauenklinik Bonn Bonn
Recruitment period and number of participants
- Planned study start date:
- 2019-10-01
- Actual study start date:
- 2019-10-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 504
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- diagnosis of an incurable cancer disease
Exclusion Criteria
- underage - no written consent - can't give consent - not well enough to participate in the study
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin Göttingen Klinik für PalliativmedizinProf. Dr. Bernd Alt-EppingRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- 0551-39-10513
- Fax:
- 0551-39-33189
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.palliativmedizin.med.uni-goettingen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- UMG- PalliativmedizinProf. Dr. Bernd Alt-EppingRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- 05513910513
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.palliativmedizin.med.uni-goettingen.de
Contact for Public Queries
- Address:
- UMGStefanie SolarVon-Siebold-Str. 337075 GöttingenGermany
- Telephone:
- 05513960559
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- UMG- PalliativmedizinProf. Dr. Bernd Alt-EppingRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- 05513910513
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.palliativmedizin.med.uni-goettingen.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Gemeinsamer BundesausschussGutenbergstr. 1310587 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.g-ba.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universitätsmedizin GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- Telephone:
- +49-551-3961261
- Fax:
- +49-551-3969536
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-01-22
- Ethics committee number:
- 23/2/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-02-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Only cooperation partners receive the anonymized tabular questionnaire data for subgroup analysis. The questionnaires will be made available after the request from our partners and after anonymization. There is no specific time limit for starting the subgroup analysis.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry