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

Treatment as Usual vs. Additional Collaborative Advance Care Planning to Improve Quality of Life for Palliative Cancer Patients: a Randomized Controlled Trial

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.

A high quality of end of life care and a "good death" as part of an improved patient centered care at the end of life have become important goals of palliative care. To achieve these goals, patient's preferences for end of life (EOL) care need to be known.

This study (randomized controlled trial) will evaluate effectiveness of a new type of advance care planning (ACP) intervention in different palliative care settings in Germany. The study addresses a new concept of ACP called collaborative advance care planning (cACP). This new concept is focusing on psychosocial barriers of patients and caregivers in addition to a standardized ACP process in order to reduce distress of patients and care-givers and enhance the chance of successful ACP-implementation. The main research questions are: a) Can cACP improve quality of life in palliative patients and caregivers?, b) Does cACP reduce distress in patients and caregivers and enhance consistency of end-of-life care? and c) Does cACP improve quality of end of life care and reduce utilization of health care resources? The investigators will try to answer theses research questions through a so called "randomized controlled trial" methodology. Admissible palliative cancer patients who are willing to participate in the trial will be randomly assigned to three groups. The first group will receive treatment as usual for palliative care patients. The second group will receive treatment as usual and an unspecific psychological intervention (sham-intervention). The third group will receive treatment as usual and the intervention designed for this trial. Both interventions will be equally long in duration and will be delivered by the same psychologists.

The primary outcome is the quality of life at 16 weeks measured by the internationally recognized "Functional Assessment of Cancer - General Version (FACT-G)" questionnaire. Secondary endpoints include measurements of the development of QoL over time, distress, depression, and the quantity of advance directives in the different groups.

Patients will be recruited in four different recruiting sites: a palliative care ward in an university hospital, an oncologists office, a rehabilitation clinic, and an outpatient palliative care network.

The study will recruit 90 patients in every group, 270 patients in total.

Inclusion Criteria:

• Patient > 18 years
• Patient with advance cancer in palliative setting
• positive surprise question: the physician will not be surprised, if the patient died in the next 12 month
• Patient is willing to take part in the study

Exclusion Criteria:

• Patients life expectancy below 3 month (estimated by physician)
• Patients ECOG-status is > 3
• Patient is not able to speak German
• Patient is incapacitated to give informed consent