Early Palliative Care – Health services research and implementation of sustainable changes

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006162
• Date of registration: 19/05/2014
• Prospective Registration: Yes
• Primary sponsor: Klinik für Pallliativmedizin, Universitätsklinikum Freiburg
• Public title: Early Palliative Care – Health services research and implementation of sustainable changes
• Scientific title: Early Palliative Care – Health services research and implementation of sustainable changes - EVI
• Date of first enrolment: 01/10/2014
• Target sample size: 2000
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00006162
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: other; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Katharina Seibel
• Affiliation: Universitätsklinikum Freiburg, Klinik für Palliativmedizin

• Name: Katharina Seibel
• Affiliation: Universitätsklinikum Freiburg, Klinik für Palliativmedizin

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

center-specific tumor entities
C34
C15
C16
C25

Malignant neoplasm of bronchus and lung

Malignant neoplasm of pancreas

Malignant neoplasm of oesophagus

Malignant neoplasm of stomach

Intervention(s)

Group 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.
Group 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.

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Robert-Bosch-Stiftung GmbH

Ethics review

Status: Approved
Approval date: 25/04/2014
Contact:

[e-mail]

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 30/07/2020
• Date Completed: 21/07/2017
• URL: http://drks.de/search/en/trial/DRKS00006162#studyResults