Early Palliative Care – Health services research and implementation of sustainable changes
Organizational Data
- DRKS-ID:
- DRKS00006162
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-05-19
- Last update in DRKS:
- 2024-01-23
- Registration type:
- Prospective
Acronym/abbreviation of the study
EVI
URL of the study
No Entry
Brief summary in lay language
At all five Comprehensive Cancer Centers throughout the federal state of Baden-Württemberg, Germany, patients with advanced metastatic cancer will routinely be offered palliative care as soon as possible after diagnosis, according to the most up-to-date international treatment standards. In each of the five participating Comprehensive Cancer Centers, an experienced palliative care physician will be hired for 18 months with a 50% position. During the preliminary phase of the study, the physician will be allowed time to establish the necessary structures for early palliative care within the clinic. In the main study phase, patients with metastatic cancer will routinely be offered a consultation with the palliative care physician within eight weeks of diagnosis. The main goal of the EVI project is to evaluate whether early palliative care can be implemented into the everyday clinical practice of Comprehensive Cancer Centers, and if so, what conditions are necessary for it to succeed. In addition, we are interested in (1) describing the type of support that patients would like from palliative care, (2) gaining information about the effect of palliative care on patients’ quality of life and healthcare costs, and (3) determining which factors could potentially ease or hinder the implementation of early palliative care, respectively. The long-term goal of this project is to create sustainable improvements in the care of patients with incurable, life-limiting cancer.
Brief summary in scientific language
The EVI project is a multi-center, prospective cohort study with a sequential control group design. The study is a project of the Palliative Care Center of Excellence (KOMPACT) in Baden-Württemberg, Germany, which was recently established to combine the expertise of five academic, specialist palliative care departments. The study is divided into two phases: preliminary phase (months 1-9) and main study phase (months 10-18). In each of all five participating academic Comprehensive Cancer Centers, an experienced palliative care physician will be hired for 18 months. During the preliminary phase, the physician will be allowed time to establish the necessary structures for early palliative care within the Comprehensive Cancer Center. In the main study phase, patients with metastatic cancer will be offered a consultation with the palliative care physician within eight weeks of diagnosis. After the initial consultation, follow-up consultations will be offered as needed. The study is built upon a converging, parallel mixed-method design. In the quantitative arm, patients will be surveyed in both the preliminary and main study phase at three points in time (baseline, 12 weeks, 24 weeks). Standardized questionnaires will be used to measure patients’ quality of life, symptom burden and mood. Using interviews with palliative care physicians, oncologists, department heads, patients and their caregivers, the qualitative arm of the study will explore (1) what factors encourage and hinder the early integration of palliative care into standard oncology care and (2) what support patients and their caregivers would like from palliative care.
Health condition or problem studied
- ICD10:
- C34 - Malignant neoplasm of bronchus and lung
- ICD10:
- C15 - Malignant neoplasm of oesophagus
- ICD10:
- C16 - Malignant neoplasm of stomach
- ICD10:
- C25 - Malignant neoplasm of pancreas
- Free text:
- center-specific tumor entities
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- In the preliminary phase patients will be recruited to establish a reference group for comparison between the status quo and those in the main study phase who receive early palliative care.
- Arm 2:
- In the main study phase, patients with metastatic cancer will routinely be offered a consultation with the palliative care physician within eight weeks of diagnosis.
Endpoints
- Primary outcome:
- The main goal of the EVI project is to evaluate whether early palliative care can be implemented into the everyday clinical practice of Comprehensive Cancer Centers, and if so, what conditions are necessary for it to succeed. We will consider early palliative care to be feasible if 75% of all eligible patients are referred to a palliative care physician at their center at least once within eight weeks of the initial diagnosis. To judge the feasibility, we will rely on the internal records of the participating centers.
- Secondary outcome:
- The study is built upon a convergent parallel design. In the quantitative arm, patients will be surveyed in both the preliminary and main study phase at three points in time (baseline, 12 weeks, 24 weeks). Standardized questionnaires will be used to measure patients’ quality of life (EORTC QLQ-C30), symptom burden (POS - Palliative Outcome Scale) and mood (Hospital Anxiety and Depression Scale - HADS-D). Using interviews with palliative care physicians, oncologists, department heads, patients and their caregivers, the qualitative arm will explore (1) what factors encourage and hinder the early integration of palliative care into standard oncology care, (2) what support patients and their caregivers would like from palliative care, and (3) what effect palliative care has on the economic disease burden of patients and their families.
Study Design
- Purpose:
- Treatment
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Heidelberg
- University medical center Tübingen
- University medical center Freiburg im Breisgau
- University medical center Ulm
Recruitment period and number of participants
- Planned study start date:
- 2014-08-01
- Actual study start date:
- 2014-10-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-07-21
- Target Sample Size:
- 2000
- Final Sample Size:
- 592
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. Initial diagnosis of a metastatic, incurable cancer (ICD 10 C 1‐80 plus ICD 10 C 78‐79) occurred within the last eight weeks, particularly: - non-small cell lung cancer (NSCLC) without epidermal growth factor (EFGR) mutations: met. NSCLC Stage IV – ICD C34.[01239] + metastasis code or C34.8 (multiple subdomains) + possibly M8012/3 (large cell carcinoma) - met. esophageal carcinoma Stage IV – ICD C15.[123459] + metastasis code or C15.8 (multiple subdomains) + possibly M8070/3 (squamous cell carcinoma) - met. stomach carcinoma Stage IV - ICD C16.[01234569] + metastasis code or C16.8 (multiple subdomains) + possibly M8145/3 (adenocarcinoma, diffuse) - non-endocrine pancreas carcinoma Stage IV - ICD C25.[012379] + metastasis code or C25.8 (multiple subdomains) + possibly M8971/3 (pancreas blastoma) - center-specific tumor entities 2. Age ≥ 18 years 3. Ability to understand written and verbal questions in German 4. Willingness to participate in the study 5. Informed consent
Exclusion Criteria
1. Other hemato-oncological disease (e.g. leukemia) 2. Dementia 3. Psychosis / delirium 4. Major depression
Addresses
Primary Sponsor
- Address:
- Klinik für Pallliativmedizin, Universitätsklinikum FreiburgProf. Gerhild BeckerRobert-Koch-Straße 379106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Freiburg, Klinik für PalliativmedizinKatharina SeibelRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270-33280
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/palliativmedizin.html
Contact for Public Queries
- Address:
- Universitätsklinikum Freiburg, Klinik für PalliativmedizinKatharina SeibelRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270-33280
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/palliativmedizin.html
Principal Investigator
- Address:
- Universitätsklinikum Freiburg, Klinik für PalliativmedizinKatharina SeibelRobert-Koch-Str. 379106 FreiburgGermany
- Telephone:
- 0761 270-33280
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/palliativmedizin.html
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Robert-Bosch-Stiftung GmbHHeidehofstr. 3170184 StuttgartGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- 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:
- 2014-04-14
- Ethics committee number:
- 193/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-04-25
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?:
- No
- IPD Sharing Plan:
- No Entry
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:
- Siemens, W., Schönsteiner, S. S., Orellana-Rios, C. L., Schaekel, U., Kessler, J., Eschbach, C., Viehrig, M., Mayer-Steinacker, R., Becker, G., & Gaertner, J. (2020). Severe symptoms and very low quality-of-life among outpatients newly diagnosed with advanced cancer: data from a multicenter cohort study. Supportive Care Cancer, 10.1007/s00520-020-05388-y. https://doi.org/10.1007/s00520-020-05388-y
- Veröffentlichung des Protokolls / publication of the study protocol
- Date of first publication of study results:
- 2020-03-17
- DRKS entry published for the first time with results:
- 2020-07-30
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry