Clinical trial NCT03387436: The "Hand-in-Hand Study": Improvement of Quality of Life in Palliative Cancer Patients Through Collaborative Advance Care Planning
Official title: Treatment as Usual vs. Additional Collaborative Advance Care Planning to Improve Quality of Life for Palliative Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Neoplasms
End Stage Cancer
Keywords: Palliative care
Advance care planning
psychological intervention
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
name: German Federal Ministry of Education and Research
name: Department of Clinical Psychology and Psychotherapy
First posted: 2018-01-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated randomly to three arms:

1. palliative treatment as usual (TAU)
2. sham-intervention + (TAU)
3. study-intervention + (TAU)

Stratification will be carried out for sex, and availability of a care giver.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Functional Assessment of Cancer Therapy scale (FACT-G; Cella, Tulsky, Gray, et al., 1993)
timeFrame: 60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); every two month for the following 8 month or till death (if occuring within one year after randomisation)
Secondary outcomes:
measure: 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, Keller, 1996)
timeFrame: 60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); every two month for the following 8 month or till death (if occuring within one year after randomisation)
measure: Functional assessment of chronic illness therapy - palliative care- 14 items (FACIT-Pal-14; Zeng et al. 2014)
timeFrame: 60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); every two month for the following 8 months or till death (if occuring one year after randomisation)
measure: National Comprehensive Cancer Network Distress Thermometer (Mehnert et al. 2006)
timeFrame: 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.)
measure: Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE-Scale, Mack et al. 2008)
timeFrame: 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.)
measure: Barriers of communication (patients)
timeFrame: 8 weeks; Baseline, 8 weeks (after randomisation: a.r.)
measure: Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001)
timeFrame: 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.)
measure: Expectations about treatment of patients (self-developed, visual analogues scale)
timeFrame: 16 weeks; Baseline, 16 weeks (a. r.)
measure: Existence of ACP directive
timeFrame: 60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); 1 year (a.r.) or after death (if occuring one year a. r.)
measure: Caregiver Quality of Life Index - Cancer Scale (CQOLC; Weitzner et al., 1999)
timeFrame: 60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); 1 year (a.r.) or after death of patient (if occuring one year a. r.)
measure: 12-Item Short Form Health Survey (SF-12; Ware, Kosinski & Keller,1996)
timeFrame: 60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); 1 year (a.r.) or after death of patient (if occuring one year a. r.)
measure: Patient Health Questionnaire - (PHQ-9; Kroenke et al., 2002)
timeFrame: Baseline
measure: Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang; Heckel et al. 2015)
timeFrame: 4-8 weeks after death of patient (if occuring within one year after randomisation)
measure: Barriers of communication (caregiver)
timeFrame: 8 weeks; Baseline, 8 weeks (after randomisation: a.r.),
measure: Expectations about treatment of patients (self-developed, visual analogues scales)
timeFrame: 16 weeks; Baseline, 16 weeks (a. r.)
measure: Inventory of Complicated Grief (Lumbeck, Brandstätter, & Geissner, 2013; Prigerson et al., 1995)
timeFrame: 4-8 weeks after death of patient (if occuring within one year after randomisation)
measure: Existence of ACP directive
timeFrame: 4-8 weeks after death of patient (if occuring within one year after randomisation)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University, Departement of Psychology, Division of Clinical Psychology and Psychtherapy
city: Marburg
country: Germany
facility: Philipps University
Study officials:
affiliation: Philipps University Marburg
name: Carola Seifart, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
name: Pia von Blanckenburg, Phd.
role: STUDY_DIRECTOR
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