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

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

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.

Keywords: Advance care planning; Complex intervention; End of life care; Palliative care; Psycho-oncological intervention.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

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Fig. 1
Study Design
Fig. 2
Fig. 2
Design and content of the col-ACP intervention

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