Advanced CancerCOLAPNCT03387436
The "Hand-in-Hand Study": Improvement of Quality of Life in Palliative Cancer Patients Through Collaborative Advance Care Planning
A study testing Study-Intervention in people with Advanced Cancer and Neoplasms, run by PD. Dr. med. Carola Seifart at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Neoplasms, End Stage Cancer
- What is being tested?
- Study-Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 2 sitesGermany
- Study dates
- 4 Dec 2017to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Enrolling by invitation
Philipps University, Departement of Psychology, Division of Clinical Psychology and Psychtherapy
Marburg, 35037
- Recruiting
Philipps University
Marburg, 35043
Martin Koch, 004964215866212, Kochmar@staff.uni-marburg.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancer, Neoplasms, End Stage Cancer
- Being tested
- Sham-Intervention, Study-Intervention
- Keywords
- Palliative care, Advance care planning, psychological intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-InterventionBehavioural
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.
Study-InterventionBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| 1.) Treatment as usual (TAU) | No intervention | Patients assigned to this arm will receive palliative treatment as usual. |
| 2.) Sham-Intervention | Sham comparator | 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. Receives: Behavioral: Sham-Intervention |
| 3.) Study-Intervention | Experimental | Patients assigned to this arm will receive the study-intervention and palliative treatment as usual. Receives: Behavioral: Study-Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (16)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4-8 weeks after death of patient (if occuring within one year after randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start4 Dec 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD. Dr. med. Carola Seifart
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, German Federal Ministry of Education and Research, Department of Clinical Psychology and Psychotherapy
- Responsible party
- Sponsor-investigator, PD. Dr. med. Carola Seifart, Philipps University Marburg
- Investigators
- Carola Seifart, PD Dr. med, Principal investigator, Philipps University MarburgPia von Blanckenburg, Phd., Study director, Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387436
- Sponsor's protocol ID
- 01GY1708
- Other IDs
- 01GY1708
- Acronym
- COLAP
- Status last verified
- Jun 2019
- First submitted
- 4 Dec 2017
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available after trial is finished. We have not decided to what extend and how we can provide the data.
Publications
Ando M, Morita T, Akechi T, Okamoto T; Japanese Task Force for Spiritual Care. Efficacy of short-term life-review interviews on the spiritual well-being of terminally ill cancer patients. J Pain Symptom Manage. 2010 Jun;39(6):993-1002. doi: 10.1016/j.jpainsymman.2009.11.320.
PubMed 20538183Chochinov HM, Hack T, Hassard T, Kristjanson LJ, McClement S, Harlos M. Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol. 2005 Aug 20;23(24):5520-5. doi: 10.1200/JCO.2005.08.391.
PubMed 16110012Bollig G, Rosland JH, Gjengedal E, Schmidt G, May AT, Heller A. A European multicenter study on systematic ethics work in nursing homes. Scand J Caring Sci. 2017 Sep;31(3):587-601. doi: 10.1111/scs.12373. Epub 2016 Aug 26.
PubMed 27561245Weitzner MA, Jacobsen PB, Wagner H Jr, Friedland J, Cox C. The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer. Qual Life Res. 1999;8(1-2):55-63. doi: 10.1023/a:1026407010614.
PubMed 10457738Weitzner MA, McMillan SC. The Caregiver Quality of Life Index-Cancer (CQOLC) Scale: revalidation in a home hospice setting. J Palliat Care. 1999 Summer;15(2):13-20.
PubMed 10425873Cohen L, Parker PA, Vence L, Savary C, Kentor D, Pettaway C, Babaian R, Pisters L, Miles B, Wei Q, Wiltz L, Patel T, Radvanyi L. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med. 2011 Apr;73(3):218-25. doi: 10.1097/PSY.0b013e31820a1c26. Epub 2011 Jan 21.
PubMed 21257977Markowitz JC, Kocsis JH, Fishman B, Spielman LA, Jacobsberg LB, Frances AJ, Klerman GL, Perry SW. Treatment of depressive symptoms in human immunodeficiency virus-positive patients. Arch Gen Psychiatry. 1998 May;55(5):452-7. doi: 10.1001/archpsyc.55.5.452.
PubMed 9596048Mack JW, Nilsson M, Balboni T, Friedlander RJ, Block SD, Trice E, Prigerson HG. Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE): validation of a scale to assess acceptance and struggle with terminal illness. Cancer. 2008 Jun;112(11):2509-17. doi: 10.1002/cncr.23476.
PubMed 18429006Zeng L, Bedard G, Cella D, Thavarajah N, Chen E, Zhang L, Bennett M, Peckham K, De Costa S, Beaumont JL, Tsao M, Danjoux C, Barnes E, Sahgal A, Chow E. Preliminary results of the generation of a shortened quality-of-life assessment for patients with advanced cancer: the FACIT-Pal-14. J Palliat Med. 2013 May;16(5):509-15. doi: 10.1089/jpm.2012.0595. Epub 2013 Apr 16.
PubMed 23590181Miller DC, Sanda MG, Dunn RL, Montie JE, Pimentel H, Sandler HM, McLaughlin WP, Wei JT. Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy. J Clin Oncol. 2005 Apr 20;23(12):2772-80. doi: 10.1200/JCO.2005.07.116.
PubMed 15837992Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Heckel M, Bussmann S, Stiel S, Weber M, Ostgathe C. Validation of the German Version of the Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang). J Pain Symptom Manage. 2015 Sep;50(3):402-13. doi: 10.1016/j.jpainsymman.2015.03.020. Epub 2015 Jun 14.
PubMed 26079825Prigerson HG, Maciejewski PK, Reynolds CF 3rd, Bierhals AJ, Newsom JT, Fasiczka A, Frank E, Doman J, Miller M. Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995 Nov 29;59(1-2):65-79. doi: 10.1016/0165-1781(95)02757-2.
PubMed 8771222Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
PubMed 8445433Mehnert, 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment as Usual vs. Additional Collaborative Advance Care Planning to Improve Quality of Life for Palliative Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03387436
- Acronym / sponsor ID
- COLAP / 01GY1708
- Conditions
- Advanced Cancer, Neoplasms, End Stage Cancer
- Keywords
- Palliative care, Advance care planning, psychological intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- PD. Dr. med. Carola SeifartUniversity, hospital or other
- Collaborators
- Philipps University Marburg, German Federal Ministry of Education and Research, Department of Clinical Psychology and Psychotherapy
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1.) Treatment as usual (TAU) | No intervention | –Patients assigned to this arm will receive palliative treatment as usual. |
| 2.) Sham-Intervention | Sham comparator | Behavioral: Sham-InterventionPatients 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. |
| 3.) Study-Intervention | Experimental | Behavioral: Study-InterventionPatients assigned to this arm will receive the study-intervention and palliative treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham-InterventionThe 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. | Behavioural | 2.) Sham-Intervention |
| Study-InterventionThe 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". | Behavioural | 3.) Study-Intervention |
Primary outcome
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.
16 secondary outcomes
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)
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)
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.)
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.)
Barriers of communication (patients)
Time frame: 8 weeks; Baseline, 8 weeks (after randomisation: a.r.)
Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001)
Time frame: 16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.)
Expectations about treatment of patients (self-developed, visual analogues scale)
Time frame: 16 weeks; Baseline, 16 weeks (a. r.)
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.)
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.)
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.)
Patient Health Questionnaire - (PHQ-9; Kroenke et al., 2002)
Time frame: Baseline
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)
Barriers of communication (caregiver)
Time frame: 8 weeks; Baseline, 8 weeks (after randomisation: a.r.),
Expectations about treatment of patients (self-developed, visual analogues scales)
Time frame: 16 weeks; Baseline, 16 weeks (a. r.)
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)
Existence of ACP directive
Time frame: 4-8 weeks after death of patient (if occuring within one year after randomisation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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- Background: PubMed 27561245Bollig G, Rosland JH, Gjengedal E, Schmidt G, May AT, Heller A. A European multicenter study on systematic ethics work in nursing homes. Scand J Caring Sci. 2017 Sep;31(3):587-601. doi: 10.1111/scs.12373. Epub 2016 Aug 26.
- Background: PubMed 10457738Weitzner MA, Jacobsen PB, Wagner H Jr, Friedland J, Cox C. The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer. Qual Life Res. 1999;8(1-2):55-63. doi: 10.1023/a:1026407010614.
- Background: PubMed 10425873Weitzner MA, McMillan SC. The Caregiver Quality of Life Index-Cancer (CQOLC) Scale: revalidation in a home hospice setting. J Palliat Care. 1999 Summer;15(2):13-20.
- Background: PubMed 21257977Cohen L, Parker PA, Vence L, Savary C, Kentor D, Pettaway C, Babaian R, Pisters L, Miles B, Wei Q, Wiltz L, Patel T, Radvanyi L. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med. 2011 Apr;73(3):218-25. doi: 10.1097/PSY.0b013e31820a1c26. Epub 2011 Jan 21.
- Background: PubMed 9596048Markowitz JC, Kocsis JH, Fishman B, Spielman LA, Jacobsberg LB, Frances AJ, Klerman GL, Perry SW. Treatment of depressive symptoms in human immunodeficiency virus-positive patients. Arch Gen Psychiatry. 1998 May;55(5):452-7. doi: 10.1001/archpsyc.55.5.452.
- Background: PubMed 18429006Mack JW, Nilsson M, Balboni T, Friedlander RJ, Block SD, Trice E, Prigerson HG. Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE): validation of a scale to assess acceptance and struggle with terminal illness. Cancer. 2008 Jun;112(11):2509-17. doi: 10.1002/cncr.23476.
- Background: PubMed 23590181Zeng L, Bedard G, Cella D, Thavarajah N, Chen E, Zhang L, Bennett M, Peckham K, De Costa S, Beaumont JL, Tsao M, Danjoux C, Barnes E, Sahgal A, Chow E. Preliminary results of the generation of a shortened quality-of-life assessment for patients with advanced cancer: the FACIT-Pal-14. J Palliat Med. 2013 May;16(5):509-15. doi: 10.1089/jpm.2012.0595. Epub 2013 Apr 16.
- Background: PubMed 15837992Miller DC, Sanda MG, Dunn RL, Montie JE, Pimentel H, Sandler HM, McLaughlin WP, Wei JT. Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy. J Clin Oncol. 2005 Apr 20;23(12):2772-80. doi: 10.1200/JCO.2005.07.116.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
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- Individual participant dataSharing planned: Undecided. Data will be made available after trial is finished. We have not decided to what extend and how we can provide the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carola Seifart, PD Dr. med principal investigator
Philipps University Marburg
Pia von Blanckenburg, Phd. study director
Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study-Intervention in people with Advanced Cancer and Neoplasms, run by PD. Dr. med. Carola Seifart at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carola Seifart, PD Dr. med. (0049/6421/5866156, carola.seifart@staff.uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387436, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.