Collaborative advance care planning in advanced cancer patients: col-ACP –study – study protocol of a randomised controlled trial

Autor: Seifart, Carola, Koch, Martin, Leppin, Nico, Nagelschmidt, Katharina, Knorrenschild, Jorge Riera, Timmesfeld, Nina, Rief, Winfried, von Blanckenburg, Pia
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: BMC Palliative Care, Vol 19, Iss 1, Pp 1-10 (2020)
BMC Palliative Care
DOI: 10.1186/s12904-020-00629-7
Popis: Background To assure patient-centred end-of-life care, palliative interventions need to account for patients’ preferences. Advance care planning (ACP) is a structured approach that allows patients, relatives and physicians to discuss end-of-life decisions. Although ACP can improve several patient related outcomes, the implementation of ACP remains difficult. The col-ACP-study (collaborative advance care planning) will investigate a new ACP procedure (col-ACP-intervention (German: Hand-in-Hand Intervention)) in palliative cancer patients and their relatives that addresses individual values and targets barriers of communication before an ACP process. Methods In a randomised controlled trial, 270 cancer patients without curative treatment options and their relatives will receive either 1) col-ACP 2) a supportive intervention (active control group) or 3) standard medical care (TAU). col-ACP comprises two steps: a) addressing various barriers of patients and relatives that discourage them from discussing end-of-life issues followed by b) a regular, structured ACP procedure. The col-ACP-intervention consists of 6 sessions. Primary endpoint is the patients’ quality of life 16 weeks after randomisation. Secondary endpoints include measurements of distress; depression; communication barriers; caregivers’ quality of life; existence of ACP or advance directives; the consistence of end of life care; and others. Patients will be followed up for 13 months. Multivariate analyses will be carried out. Qualitative evaluation of the intervention will be conducted. Discussion Augmentation of a regular ACP program by a structured psycho-oncological intervention is an innovative approach to target barriers of communication about end-of-life issues. Study findings will help to understand the value of such a combined intervention in palliative care. Trial registration ClinicalTrials.gov Identifier: NCT03387436 (Date of registration: 01/02/2018, retrospectively registered.
Databáze: OpenAIRE
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