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

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ClinicalTrials.gov Identifier: NCT03387436
Recruitment Status : Recruiting
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Advanced Cancer Neoplasms End Stage Cancer Behavioral: Sham-Intervention Behavioral: Study-Intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

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.

Primary Purpose: Supportive Care
Official Title: Treatment as Usual vs. Additional Collaborative Advance Care Planning to Improve Quality of Life for Palliative Cancer Patients: a Randomized Controlled Trial
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : September 1, 2020
Arms and Interventions

Arm Intervention/treatment
No Intervention: 1.) Treatment as usual (TAU)
Patients assigned to this arm will receive palliative treatment as usual.
Sham Comparator: 2.) Sham-Intervention
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
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.
Experimental: 3.) Study-Intervention
Patients assigned to this arm will receive the study-intervention and palliative treatment as usual.
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".



Outcome Measures

Primary Outcome Measures :
  1. The Functional Assessment of Cancer Therapy scale (FACT-G; Cella, Tulsky, Gray, et al., 1993) [ Time Frame: 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 Outcome Measures :
  1. 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, Keller, 1996) [ Time Frame: 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.

  2. Functional assessment of chronic illness therapy - palliative care- 14 items (FACIT-Pal-14; Zeng et al. 2014) [ Time Frame: 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.

  3. National Comprehensive Cancer Network Distress Thermometer (Mehnert et al. 2006) [ Time Frame: 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.

  4. Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE-Scale, Mack et al. 2008) [ Time Frame: 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)


  5. Barriers of communication (patients) [ Time Frame: 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.


  6. Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001) [ Time Frame: 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

  7. Expectations about treatment of patients (self-developed, visual analogues scale) [ Time Frame: 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)

  8. Existence of ACP directive [ Time Frame: 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)

  9. Caregiver Quality of Life Index - Cancer Scale (CQOLC; Weitzner et al., 1999) [ Time Frame: 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)


  10. 12-Item Short Form Health Survey (SF-12; Ware, Kosinski & Keller,1996) [ Time Frame: 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.

  11. Patient Health Questionnaire - (PHQ-9; Kroenke et al., 2002) [ Time Frame: 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


  12. Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang; Heckel et al. 2015) [ Time Frame: 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.

  13. Barriers of communication (caregiver) [ Time Frame: 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.

  14. Expectations about treatment of patients (self-developed, visual analogues scales) [ Time Frame: 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)

  15. Inventory of Complicated Grief (Lumbeck, Brandstätter, & Geissner, 2013; Prigerson et al., 1995) [ Time Frame: 4-8 weeks after death of patient (if occuring within one year after randomisation) ]
    Complicated grief, 19 items, sumscore (0-76, cut-off >25)

  16. Existence of ACP directive [ Time Frame: 4-8 weeks after death of patient (if occuring within one year after randomisation) ]
    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)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387436


Contacts
Contact: Carola Seifart, PD Dr. med. 0049/6421/5866156 carola.seifart@staff.uni-marburg.de
Contact: Pia von Blanckenburg, Ph. D 0049/6421/2824051 pia.vonblanckenburg@staff.uni-marburg.de

Locations
Germany
Philipps University, Departement of Psychology, Division of Clinical Psychology and Psychtherapy Enrolling by invitation
Marburg, Germany, 35037
Philipps University Recruiting
Marburg, Germany, 35043
Contact: Martin Koch    004964215866212    Kochmar@staff.uni-marburg.de   
Sponsors and Collaborators
PD. Dr. med. Carola Seifart
Philipps University Marburg Medical Center
German Federal Ministry of Education and Research
Department of Clinical Psychology and Psychotherapy
Investigators
Principal Investigator: Carola Seifart, PD Dr. med Philipps University Marburg Medical Center
Study Director: Pia von Blanckenburg, Phd. Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
More Information

Publications:
Mehnert, Anja; Müller, Diana; Lehmann, Claudia; Koch, Uwe (2006): Die deutsche Version des NCCN Distress-Thermometers. In: Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 54 (3), S. 213-223. DOI: 10.1024/1661-4747.54.3.213.
Lumbeck, Gudrun; Brandstätter, Monika; Geissner, Edgar (2012): Erstvalidierung der deutschen Version des "Inventory of Complicated Grief" (ICG-D). In: Zeitschrift für Klinische Psychologie und Psychotherapie 41 (4), p. 243-248.

Responsible Party: PD. Dr. med. Carola Seifart, Sponsor-Investigator, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03387436     History of Changes
Other Study ID Numbers: 01GY1708
01GY1708 ( Other Grant/Funding Number: Federal Ministry of Education and Research )
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be made available after trial is finished. We have not decided to what extend and how we can provide the data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PD. Dr. med. Carola Seifart, Philipps University Marburg Medical Center:
Palliative care
Advance care planning
psychological intervention