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

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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.

Related collections

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This study examined a novel intervention, dignity therapy, designed to address psychosocial and existential distress among terminally ill patients. Dignity therapy invites patients to discuss issues that matter most or that they would most want remembered. Sessions are transcribed and edited, with a returned final version that they can bequeath to a friend or family member. The objective of this study was to establish the feasibility of dignity therapy and determine its impact on various measures of psychosocial and existential distress. Terminally ill inpatients and those receiving home-based palliative care services in Winnipeg, Canada, and Perth, Australia, were asked to complete pre- and post-intervention measures of sense of dignity, depression, suffering, and hopelessness; sense of purpose, sense of meaning, desire for death, will to live, and suicidality; and a post-intervention satisfaction survey. Ninety-one percent of participants reported being satisfied with dignity therapy; 76% reported a heightened sense of dignity; 68% reported an increased sense of purpose; 67% reported a heightened sense of meaning; 47% reported an increased will to live; and 81% reported that it had been or would be of help to their family. Post-intervention measures of suffering showed significant improvement (P = .023) and reduced depressive symptoms (P = .05). Finding dignity therapy helpful to their family correlated with life feeling more meaningful (r = 0.480; P = .000) and having a sense of purpose (r = 0.562; P = .000), accompanied by a lessened sense of suffering (r = 0.327; P = .001) and increased will to live (r = 0.387; P = .000). Dignity therapy shows promise as a novel therapeutic intervention for suffering and distress at the end of life.

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Author and article information

Contributors

Pia von Blanckenburg:

ORCID: http://orcid.org/0000-0001-7899-9828

blanckep@uni-marburg.de

Journal

Journal ID (nlm-ta): BMC Palliat Care

Journal ID (iso-abbrev): BMC Palliat Care

Title: BMC Palliative Care

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-684X

Publication date (Electronic): 24 August 2020

Publication date PMC-release: 24 August 2020

Publication date Collection: 2020

Volume: 19

Electronic Location Identifier: 134

Affiliations

[1 ]GRID grid.10253.35, ISNI 0000 0004 1936 9756, Institutional Review Board, Clinical Ethics, , Philipps-University Marburg, ; Marburg, Germany

[2 ]GRID grid.10253.35, ISNI 0000 0004 1936 9756, Department of Clinical Psychology and Psychotherapy, , Philipps-University Marburg, ; Gutenbergstraße 18, 35032 Marburg, Germany

[3 ]GRID grid.411067.5, ISNI 0000 0000 8584 9230, Department of Internal Medicine, Division Hematology and Oncology, , University Clinic of Gießen and Marburg, ; Marburg, Germany

[4 ]GRID grid.5570.7, ISNI 0000 0004 0490 981X, Department of Medical Informatics, Biometry and Epidemiology, , Ruhr-University Bochum, ; Bochum, Germany

Author information

Pia von Blanckenburg http://orcid.org/0000-0001-7899-9828

Article

Publisher ID: 629

DOI: 10.1186/s12904-020-00629-7

PMC ID: 7445911

PubMed ID: 32838763

SO-VID: 90c5e10a-0e99-4f19-846e-1e3a0ce775ac

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 20 May 2020

Date accepted : 6 August 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100002347, Bundesministerium für Bildung und Forschung;

Award ID: 01GY1708

Award Recipient : Carola Seifart

Custom metadata

ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: advance care planning,psycho-oncological intervention,palliative care,end of life care,complex intervention

Data availability: