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

Not Applicable

• Conditions: center-specific tumor entities; C34; C15; C16; Malignant neoplasm of bronchus and lung; C25; Malignant neoplasm of oesophagus; Malignant neoplasm of stomach; Malignant neoplasm of pancreas

• Registration Number: DRKS00006162
• Lead Sponsor: Klinik für Pallliativmedizin, Universitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-19
• Study Completion: 2017-07-21
• Results First Posted: 2020-03-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 592

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.