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01-12-2020 | Care | Study protocol

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

Authors: Carola Seifart, Martin Koch, Nico Leppin, Katharina Nagelschmidt, Jorge Riera Knorrenschild, Nina Timmesfeld, Winfried Rief, Pia von Blanckenburg

Published in: BMC Palliative Care | Issue 1/2020

Abstract

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.

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Title: Collaborative advance care planning in advanced cancer patients: col-ACP –study – study protocol of a randomised controlled trial
Authors: Carola Seifart
Martin Koch
Nico Leppin
Katharina Nagelschmidt
Jorge Riera Knorrenschild
Nina Timmesfeld
Winfried Rief
Pia von Blanckenburg
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Care
Living Will
Published in: BMC Palliative Care / Issue 1/2020
Electronic ISSN: 1472-684X
DOI: https://doi.org/10.1186/s12904-020-00629-7

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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