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

Study Overview
=================
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.

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

Conditions
-----------------
Advanced Cancer, Neoplasms, End Stage Cancer

Intervention / Treatment
-----------------
* Behavioral: Sham-Intervention
* Behavioral: Study-Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be allocated randomly to three arms: palliative treatment as usual (TAU) sham-intervention + (TAU) study-intervention + (TAU) Stratification will be carried out for sex, and availability of a care giver.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1.) Treatment as usual (TAU)<br>Patients assigned to this arm will receive palliative treatment as usual. | |
| Sham Comparator: 2.) Sham-Intervention<br>Patients assigned to this arm will receive an sham intervention with unspecific supportive therapy (i.e. listening, empathy etc., but no specific intervention rationale) and palliative treatment as usual. | Behavioral: Sham-Intervention<br>* 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.<br>|
| Experimental: 3.) Study-Intervention<br>Patients assigned to this arm will receive the study-intervention and palliative treatment as usual. | Behavioral: Study-Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Functional Assessment of Cancer Therapy scale (FACT-G; Cella, Tulsky, Gray, et al., 1993) | Quality of life (QOL). Self-rating measurement; four subscales: physical well-being (7-items, score range 0-28), social/ family well-being (7-items, score range 0-28), emotional well being (6-items, score range 0-24) and functional well being (7-items, score range 0-28), one total score (sum of the four subscale scores; score range of 0-108). Higher subscale and total scores indicate better QoL. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, Keller, 1996) | QOL of patients. Two subscales of health related quality of life (QOL): physical health and mental health (score range:0-100). Higher scores indicate better QoL. | 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) | 
| Functional assessment of chronic illness therapy - palliative care- 14 items (FACIT-Pal-14; Zeng et al. 2014) | QoL of palliative care patients. A higher score indicate better QoL. | 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) | 
| National Comprehensive Cancer Network Distress Thermometer (Mehnert et al. 2006) | scale from 0 to 10 assessing overall psycho social distress, was specifically developed for oncological patients. | 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.) | 
| Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE-Scale, Mack et al. 2008) | The scale was developed to assess the acceptance of the disease and the inner peace of patients. 12 items, two subscales: inner acceptance of disease (score 0-20 high number indicating high acceptance), inner conflict with disease (score 0-28 high score indicating more conflict) | 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.) | 
| Barriers of communication (patients) | This self developed questionnaire will try to assess the barriers of communication of patients and caregivers concerning topics like end of life care and death. 25 items, 6 point likert scale. High score indicating low barriers of communication (some reverse scored items). The scale will be validated in the study. | 8 weeks; Baseline, 8 weeks (after randomisation: a.r.) | 
| Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001) | Assesses severe symptoms of depression based on criteria by the DSM IV. 9 items, sumscore (0-27), a high sumscore indicates a high level of depression | 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.) | 
| Expectations about treatment of patients (self-developed, visual analogues scale) | These three self-developed items assess descriptive 1. the expectations patients have towards their cancer therapy (e.g. prolonging of life, improvement of QoL) and 2. the importance of prolonging of life & improvement of QoL (two visual analogues scales) | 16 weeks; Baseline, 16 weeks (a. r.) | 
| Existence of ACP directive | Patients will be asked, if they have completed and advance healthcare directive or took part in an ACP-process. Purely descriptive (Advance directive yes vs. no) | 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.) | 
| Caregiver Quality of Life Index - Cancer Scale (CQOLC; Weitzner et al., 1999) | Assessment of cancer caregivers QoL and has been validated in curative and palliative settings. 34 items, 5 point likert scale, high score indicating low QoL (some items reverse scoreed) | 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.) | 
| 12-Item Short Form Health Survey (SF-12; Ware, Kosinski & Keller,1996) | QOL of caregivers. Two subscales of health related quality of life (QOL): physical health and mental health (score range:0-100). Higher scores indicate better QoL. | 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.) | 
| Patient Health Questionnaire - (PHQ-9; Kroenke et al., 2002) | Depression of caregivers. Assesses severe symptoms of depression based on criteria by the DSM IV. 9 items, sumscore (range 0-27), a high sumscore indicates a high level of depression | Baseline | 
| Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang; Heckel et al. 2015) | The QODD-questionnaire (Qualitiy of dying and death) assesses the quality of the deceasing phase from a caregivers perspective.QODD-D-Ang total score (sumscore range 0-100); higher scores indicate better Quality of dying and death. | 4-8 weeks after death of patient (if occuring within one year after randomisation) | 
| Barriers of communication (caregiver) | This self developed questionnaire will try to assess the barriers of communication of patients and caregivers concerning topics like end of life care and death. The scale will be validated in the study. Higher scores indicate more barriers of communication. | 8 weeks; Baseline, 8 weeks (after randomisation: a.r.), | 
| Expectations about treatment of patients (self-developed, visual analogues scales) | These three self-developed items assess descriptive 1. the expectations caregivers have towards their relatives cancer therapy (e.g. prolonging of life, improvement of QoL) and 2. the importance of prolonging of life & improvement of QoL (two visual analogues scales) | 16 weeks; Baseline, 16 weeks (a. r.) | 
| Inventory of Complicated Grief (Lumbeck, Brandstätter, & Geissner, 2013; Prigerson et al., 1995) | Complicated grief, 19 items, sumscore (0-76, cut-off >25) | 4-8 weeks after death of patient (if occuring within one year after randomisation) | 
| Existence of ACP directive | Caregivers will be asked, if the patient has completed and advance healthcare directive or took part in an ACP-process. Purely descriptive (Advance directive yes vs. no) | 4-8 weeks after death of patient (if occuring within one year after randomisation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative care, Advance care planning, psychological intervention