The "Hand-in-Hand Study": Improvement of Quality of Life in Palliative Cancer Patients Through Collaborative Advance Care Planning

Summary

This study evaluates the effect of a collaborative advance care planning intervention on the quality of life in palliative oncological patients. Research indicates, that talking about wishes for end of life care and death, may improve the quality of life, but can be difficult for involved parties.

The intervention especially developed for this study trys to reduce psychosocial barriers that make conversations about these topics difficult. The study will measure the effect of the intervention on patients and caregivers quality of life.

The study will give additional information about implementation of advance care planning interventions in different care settings in a complex health care systems.

Conditions

• Advanced Cancer
• Neoplasms
• End Stage Cancer

Interventions

BEHAVIORAL

Sham-Intervention

The sham intervention does not target the specific topics of the study intervention group (i.e. no special focus an ACP or end of life communication). Supportive therapy uses common factors of psychotherapy such as elicitation of affect, reflective listening, and feeling understood, but provides no explicit theoretical formulation to the patient. The therapist tries to elicit and validate the patients' affect for instance on the realization that there is no curative treatment option. Supportive therapy has been used as an unspecific control condition in several studies (Cohen et al. 2011; Markowitz et al. 1998). Patients of the sham intervention will be informed about the benefits of advance directives in general.

BEHAVIORAL

Study-Intervention

The design of the study-intervention was influenced by dignity therapy (Chochinov et al. 2005), the End-of-life-Review (Ando et al. 2010) and barriers concerning participation of ACP identified by research (Bollig et al. 2017; Gjerberg et al. 2015). It is the goal of the study-intervention to enhance communication about death related topics of patients and their relatives/caregivers. Our study intervention extends over six therapeutic sessions. The length of each session will be adjusted to the patients physical condition, it should not exceed 45 minutes in total. In the first four sessions, patients and relatives will be informed about the relevance of ACP. Potential barriers for an efficient patient-caregiver communication and ACP are discussed. The intervention focuses on encouraging end-of-life communication and on jointly modifying barriers to EOL communication. The fifth and sixth session focus on ACP based on the standardised concept of "beizeiten begleiten".

Sponsors & Collaborators

• Philipps University Marburg

  collaborator OTHER

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Department of Clinical Psychology and Psychotherapy

  collaborator UNKNOWN

• PD. Dr. med. Carola Seifart

  lead OTHER

Principal Investigators

• Carola Seifart, PD Dr. med · Philipps University Marburg

• Pia von Blanckenburg, Phd. · Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-04

Primary Completion

2020-01-01

Completion

2020-09-01

Countries

• Germany

Study Locations