Advanced Cancer, End Stage Cancer, Neoplasms
Conditions
Keywords
Palliative care, Advance care planning, psychological intervention
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.
Interventions
BEHAVIORALSham-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.
BEHAVIORALStudy-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
Philipps University Marburg
German Federal Ministry of Education and Research
Department of Clinical Psychology and Psychotherapy
PD. Dr. med. Carola Seifart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
As in most psychological interventions, care providers (psychologists) can not be blinded, because they are delivering the intervention. Patients only know if they are in one of the intervention groups or in TAU. All other study personnel will be blinded.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Cancer Therapy scale (FACT-G; Cella, Tulsky, Gray, et al., 1993) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional assessment of chronic illness therapy - palliative care- 14 items (FACIT-Pal-14; Zeng et al. 2014) | 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) | QoL of palliative care patients. A higher score indicate better QoL. |
| National Comprehensive Cancer Network Distress Thermometer (Mehnert et al. 2006) | 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.) | scale from 0 to 10 assessing overall psycho social distress, was specifically developed for oncological patients. |
| Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE-Scale, Mack et al. 2008) | 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.) | 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) |
| Barriers of communication (patients) | 8 weeks; Baseline, 8 weeks (after randomisation: a.r.) | 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. |
| Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001) | 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.) | 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 |
| Expectations about treatment of patients (self-developed, visual analogues scale) | 16 weeks; Baseline, 16 weeks (a. r.) | 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) |
| Existence of ACP directive | 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.) | 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) |
| 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, Keller, 1996) | 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) | 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. |
| 12-Item Short Form Health Survey (SF-12; Ware, Kosinski & Keller,1996) | 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.) | 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. |
| Patient Health Questionnaire - (PHQ-9; Kroenke et al., 2002) | Baseline | 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 |
| Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang; Heckel et al. 2015) | 4-8 weeks after death of patient (if occuring within one year after randomisation) | 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. |
| Barriers of communication (caregiver) | 8 weeks; Baseline, 8 weeks (after randomisation: a.r.), | 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. |
| Expectations about treatment of patients (self-developed, visual analogues scales) | 16 weeks; Baseline, 16 weeks (a. r.) | 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) |
| Inventory of Complicated Grief (Lumbeck, Brandstätter, & Geissner, 2013; Prigerson et al., 1995) | 4-8 weeks after death of patient (if occuring within one year after randomisation) | Complicated grief, 19 items, sumscore (0-76, cut-off \>25) |
| Caregiver Quality of Life Index - Cancer Scale (CQOLC; Weitzner et al., 1999) | 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.) | 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) |
Countries
Germany
Contacts
Primary ContactCarola Seifart, PD Dr. med.
Backup ContactPia von Blanckenburg, Ph. D
Outcome results
None listed