Metastatic CancerPhase 4DanPaCTNCT01348048
A Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction
A Phase 4 study testing Specialised palliative care (SPC) in people with Metastatic Cancer, run by Bispebjerg Hospital at 6 sites in Denmark.
Trial summary
Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Specialised palliative care (SPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 6 sitesDenmark
- Study dates
- May 2011to Oct 2014
- Phase
- Phase 4
- 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
- Cancer stage 4 according to the TNM system (for patients with cancer in CNS inclusion criteria is: cancer grade three or four and no possibility of radical treatment)
- At least 18 years
- Live in the area of the participating hospitals
- No contact with specialised palliative care within the previous year
- At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
- Four additional symptoms (defined as patients answering, on average, at least 'a little' in any of the 14 function or symptom scales in the EORTC QLQ-C30 questionnaire)
- Written informed consent
Who cannot join
- Do not understand Danish well enough to participate in the study
- Are judged incapable of co-operating with the trial protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
The Palliative Team, Aarhus University Hospital
Aarhus, 8000
Section of Acute Pain Management and Palliative Medicine, Rigshospitalet
Copenhagen, 2100
Department of Palliative Medicine, Bispebjerg Hospital
Copenhagen, 2400
Palliative Team Herning
Herning, 7400
Palliative Team Fyn, Odense University hospital
Nyborg, 5800
Palliative Team Vejle
Vejle, 7100
About this study
Official title: Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.
Read the detailed description
The trial is a randomised, clinical, multicenter trial including 6 Danish SPC-centres. The basic principle is that patients with palliative needs (see inclusion criteria) are identified at oncological departments and randomised to either (i) standard treatment plus SPC (intervention group) or (ii) standard treatment (control group).
Patients will be identified by the following procedure: A) Each week a research nurse reviews the medical records of consecutive patients seen in oncological out-patients clinic. B) Eligible patients are asked to fill out a questionnaire (the screening) that investigates symptoms and problems. The patients are told that their questionnaire will be evaluated and that the research nurse will contact some of the patients later on with information about a RCT. C) Those patients who report at least one palliative need in the questionnaire (see inclusion criteria) and have four additional symptoms are contacted by the research nurse who provide the patients with written and verbal information about the RCT. D) Patients who give informed consent are randomised.
Detailed statistical analysis plan:
Analysis of the primary outcome The primary outcome analysis will be a modified ITT analysis. Patients who withdrew consent after randomisation, who were randomised by mistake and did not fulfil our inclusion criteria, or who were not alive at the time of the follow-ups, will be excluded from the primary analysis. All exclusions will be shown in the CONSORT flow-chart of patient participation.
In the primary outcome analysis we will use multiple imputation for non-responders if there are more than 5% missing outcomes. In total, we will make 20 different data-sets with imputation based on a regression model using predictive-mean-matching using the MI and the MI ANALYSIS procedures in SAS. The primary outcome analysis will be made as a multiple regressions adjusted for the stratification variable if it is normally distributed.
Sensitivity analyses of the primary outcome We will make five sensitivity analyses: 1) a fully adjusted analysis including all relevant covariates, 2) a complete case analysis, 3) an analysis including a model for repeated measurement, 4) a per protocol analysis, 5) an analysis including imputations for those who died.
Analysis of secondary outcomes The analyses of the seven scales from EORTC QLQ-C30 (physical function, role function, emotional function, nausea and vomiting, pain, dyspnoea, or lack of appetite) will be made using the same principles as described for the primary outcome including the sensitivity analyses. Survival will be analysed using Kaplan-Meier plot. Patients who are alive three months after the end of data-collection will be censured on this date. A Cox regression will be made adjusted for the stratification variable. A sensitivity analysis will be made adjusting for all relevant covariates.
Exploratory outcomes and subgroup analyses For serious adverse events we report the number of hospitalisations, the number of acute hospitalisations and the number of deaths in the eight week trial period. The analyses of the other exploratory outcomes will not be dealt with in detail here. The overall principles regarding questionnaire data (the remaining scales from EORTC QLQ-C30, HADS and FAMCARE-P16) are that they will be analysed as complete case analyses.
Significance levels All tests will be two-tailed. For the primary outcome the risk of type I error is set to 5% (i.e., a significance level of P<0.05). As we have 8 secondary outcomes, we adjust the significance levels to P<0.01 to control the familywise (or cumulative) type I error due to multiplicity. The P-values of the exploratory outcomes will be provided, but it will be made clear that the analyses are exploratory.
Register-data, data-management and analyses Survival will be retrieved from the Danish Civil Registration System (CPR), and serious adverse events and contacts from The Danish Patient Registry (Landspatientregistret).
Data management will be done by project manager Anna Thit Johnsen. Analyses will be made by statistician Morten Aa. Petersen, who is blinded to the identity of the two intervention groups, which will be denoted Y and X. Results will be presented blinded in the same way for the investigators, and conclusions regarding the results will be drawn by the investigators and written down while the interventions are still blinded. The blinding will not be broken before all analyses of primary and secondary outcomes have been conducted.
- Conditions
- Metastatic Cancer
- Being tested
- Specialised palliative care (SPC)
- Keywords
- palliative care, end-of-life care, randomized clinical trial, quality of life, needs assessment, patient satisfaction, cost-effectiveness, Screening
- Medical subject headings
- Neoplasm Metastasis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialised palliative care (SPC)Other
The interventions given by the SPC centres follow the the WHO and the EAPC guidelines for palliative care. It is not possible in advance to describe the interventions more specifically as these will be adjusted to each particular patient. As part of the study the medical records of all patients in the intervention group will be reviewed with the purpose of describing the interventions given for the different symptoms and problems.
| Study group | Role | What they receive |
|---|---|---|
| Specialised palliative care (SPC) group | Experimental | Patients continue with their standard treatment (typically they receive treatment in one or more hospitals departments and from their GP). In addition, they are offered a consultation in the SPC out-patient clinic (or at home if the patient cannot attend the hospital) as soon as possible and no more than one week after randomization. If possible, each patient will have at least two contacts to the SPC in the trial period. Receives: Other: Specialised palliative care (SPC) |
| Standard care group | No intervention | Patients continue with their standard treatment. They are instructed to contact either their GP or their hospital department if they feel that additional treatment or care is needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need
The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale score that constitutes the primary need. The primary need can be a need related to the following: physical function, role function, emotional function, pain, shortness of breath, lack of appetite and nausea/vomiting.
Measured: Baseline, 3 weeks and 8 weeks
Secondary outcomes (4)
Patients reported symptoms and problems according to the EORTC QLQ-C30
The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for all the symptoms and problems measured by the EORTC QLQ-C30 and for anxiety and depression measured by the The Hospital Anxiety and Depression Scale (HAD scale)
Measured: Baseline, 3 weeks and 8 weeks
Survival
Survival.
Measured: From the start of the trial to minimum three months after the end of the intervention.
Economical consequences
Economical consequences measured as the expenses to health care services (treatments, hospitalisation, outpatient visits, emergency room visits, and visits with the general practitioner).
Measured: From the start of the trial to minimum three months after the end of the intervention.
Patient reported Satisfaction with services provided by the health care system measured with the questionnaire FAMCARE-p16
The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) in the patients' evaluation of treatment and care provided by the health care system measured by the FAMCARE-p16 and four additional items developed for this trial
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Danish Cancer Society
- Responsible party
- Principal investigator, Mogens Groenvold, Bispebjerg Hospital
- Investigators
- Mogens Groenvold, MD, PhD, DMSc, Principal investigator, Department of Palliative Medicine, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348048
- Sponsor's protocol ID
- DanPaCT2011
- Acronym
- DanPaCT
- Status last verified
- Feb 2015
- First submitted
- 2 May 2011
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnsen AT, Damkier A, Vejlgaard TB, Lindschou J, Sjogren P, Gluud C, Neergaard MA, Petersen MA, Lundorff LE, Pedersen L, Fayers P, Stromgren AS, Higginson IJ, Groenvold M. A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol. BMC Palliat Care. 2013 Oct 24;12(1):37. doi: 10.1186/1472-684X-12-37.
PubMed 24152880Johnsen AT, Petersen MA, Gluud C, Lindschou J, Fayers P, Sjogren P, Pedersen L, Neergaard MA, Vejlgaard TB, Damkier A, Nielsen JB, Stromgren AS, Higginson IJ, Groenvold M. Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT). Trials. 2014 Sep 26;15:376. doi: 10.1186/1745-6215-15-376.
PubMed 25257804Skjoedt N, Johnsen AT, Sjogren P, Neergaard MA, Damkier A, Gluud C, Lindschou J, Fayers P, Higginson IJ, Stromgren AS, Groenvold M. Early specialised palliative care: interventions, symptoms, problems. BMJ Support Palliat Care. 2021 Dec;11(4):444-453. doi: 10.1136/bmjspcare-2019-002043. Epub 2020 Mar 27.
PubMed 32220944Johnsen AT, Petersen MA, Sjogren P, Pedersen L, Neergaard MA, Damkier A, Gluud C, Fayers P, Lindschou J, Stromgren AS, Nielsen JB, Higginson IJ, Groenvold M. Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients. Support Care Cancer. 2020 May;28(5):2145-2155. doi: 10.1007/s00520-019-05021-7. Epub 2019 Aug 13.
PubMed 31410598Groenvold M, Petersen MA, Damkier A, Neergaard MA, Nielsen JB, Pedersen L, Sjogren P, Stromgren AS, Vejlgaard TB, Gluud C, Lindschou J, Fayers P, Higginson IJ, Johnsen AT. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial. Palliat Med. 2017 Oct;31(9):814-824. doi: 10.1177/0269216317705100. Epub 2017 May 12.
PubMed 28494643
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
- ClinicalTrials.gov ID
- NCT01348048
- Acronym / sponsor ID
- DanPaCT / DanPaCT2011
- Conditions
- Metastatic Cancer
- Keywords
- palliative care, end-of-life care, randomized clinical trial, quality of life, needs assessment, patient satisfaction, cost-effectiveness, Screening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- TRYG Foundation, Danish Cancer Society
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 May 2011 (estimated)
- 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.
Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.
Detailed description
The trial is a randomised, clinical, multicenter trial including 6 Danish SPC-centres. The basic principle is that patients with palliative needs (see inclusion criteria) are identified at oncological departments and randomised to either (i) standard treatment plus SPC (intervention group) or (ii) standard treatment (control group).
Patients will be identified by the following procedure: A) Each week a research nurse reviews the medical records of consecutive patients seen in oncological out-patients clinic. B) Eligible patients are asked to fill out a questionnaire (the screening) that investigates symptoms and problems. The patients are told that their questionnaire will be evaluated and that the research nurse will contact some of the patients later on with information about a RCT. C) Those patients who report at least one palliative need in the questionnaire (see inclusion criteria) and have four additional symptoms are contacted by the research nurse who provide the patients with written and verbal information about the RCT. D) Patients who give informed consent are randomised.
Detailed statistical analysis plan:
Analysis of the primary outcome The primary outcome analysis will be a modified ITT analysis. Patients who withdrew consent after randomisation, who were randomised by mistake and did not fulfil our inclusion criteria, or who were not alive at the time of the follow-ups, will be excluded from the primary analysis. All exclusions will be shown in the CONSORT flow-chart of patient participation.
In the primary outcome analysis we will use multiple imputation for non-responders if there are more than 5% missing outcomes. In total, we will make 20 different data-sets with imputation based on a regression model using predictive-mean-matching using the MI and the MI ANALYSIS procedures in SAS. The primary outcome analysis will be made as a multiple regressions adjusted for the stratification variable if it is normally distributed.
Sensitivity analyses of the primary outcome We will make five sensitivity analyses: 1) a fully adjusted analysis including all relevant covariates, 2) a complete case analysis, 3) an analysis including a model for repeated measurement, 4) a per protocol analysis, 5) an analysis including imputations for those who died.
Analysis of secondary outcomes The analyses of the seven scales from EORTC QLQ-C30 (physical function, role function, emotional function, nausea and vomiting, pain, dyspnoea, or lack of appetite) will be made using the same principles as described for the primary outcome including the sensitivity analyses. Survival will be analysed using Kaplan-Meier plot. Patients who are alive three months after the end of data-collection will be censured on this date. A Cox regression will be made adjusted for the stratification variable. A sensitivity analysis will be made adjusting for all relevant covariates.
Exploratory outcomes and subgroup analyses For serious adverse events we report the number of hospitalisations, the number of acute hospitalisations and the number of deaths in the eight week trial period. The analyses of the other exploratory outcomes will not be dealt with in detail here. The overall principles regarding questionnaire data (the remaining scales from EORTC QLQ-C30, HADS and FAMCARE-P16) are that they will be analysed as complete case analyses.
Significance levels All tests will be two-tailed. For the primary outcome the risk of type I error is set to 5% (i.e., a significance level of P<0.05). As we have 8 secondary outcomes, we adjust the significance levels to P<0.01 to control the familywise (or cumulative) type I error due to multiplicity. The P-values of the exploratory outcomes will be provided, but it will be made clear that the analyses are exploratory.
Register-data, data-management and analyses Survival will be retrieved from the Danish Civil Registration System (CPR), and serious adverse events and contacts from The Danish Patient Registry (Landspatientregistret).
Data management will be done by project manager Anna Thit Johnsen. Analyses will be made by statistician Morten Aa. Petersen, who is blinded to the identity of the two intervention groups, which will be denoted Y and X. Results will be presented blinded in the same way for the investigators, and conclusions regarding the results will be drawn by the investigators and written down while the interventions are still blinded. The blinding will not be broken before all analyses of primary and secondary outcomes have been conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialised palliative care (SPC) group | Experimental | Other: Specialised palliative care (SPC)Patients continue with their standard treatment (typically they receive treatment in one or more hospitals departments and from their GP). In addition, they are offered a consultation in the SPC out-patient clinic (or at home if the patient cannot attend the hospital) as soon as possible and no more than one week after randomization. If possible, each patient will have at least two contacts to the SPC in the trial period. |
| Standard care group | No intervention | –Patients continue with their standard treatment. They are instructed to contact either their GP or their hospital department if they feel that additional treatment or care is needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cancer stage 4 according to the TNM system (for patients with cancer in CNS inclusion criteria is: cancer grade three or four and no possibility of radical treatment)
- At least 18 years
- Live in the area of the participating hospitals
- No contact with specialised palliative care within the previous year
- At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
Key exclusion criteria (2 listed)
- Do not understand Danish well enough to participate in the study
- Are judged incapable of co-operating with the trial protocol
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 |
|---|---|---|
| Specialised palliative care (SPC)The interventions given by the SPC centres follow the the WHO and the EAPC guidelines for palliative care. It is not possible in advance to describe the interventions more specifically as these will be adjusted to each particular patient. As part of the study the medical records of all patients in the intervention group will be reviewed with the purpose of describing the interventions given for the different symptoms and problems. | Other | Specialised palliative care (SPC) group |
Primary outcome
Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need
Time frame: Baseline, 3 weeks and 8 weeks
The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale score that constitutes the primary need. The primary need can be a need related to the following: physical function, role function, emotional function, pain, shortness of breath, lack of appetite and nausea/vomiting.
4 secondary outcomes
Patients reported symptoms and problems according to the EORTC QLQ-C30
Time frame: Baseline, 3 weeks and 8 weeks
Survival
Time frame: From the start of the trial to minimum three months after the end of the intervention.
Economical consequences
Time frame: From the start of the trial to minimum three months after the end of the intervention.
Patient reported Satisfaction with services provided by the health care system measured with the questionnaire FAMCARE-p16
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Background: PubMed 24152880Johnsen AT, Damkier A, Vejlgaard TB, Lindschou J, Sjogren P, Gluud C, Neergaard MA, Petersen MA, Lundorff LE, Pedersen L, Fayers P, Stromgren AS, Higginson IJ, Groenvold M. A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol. BMC Palliat Care. 2013 Oct 24;12(1):37. doi: 10.1186/1472-684X-12-37.
- Background: PubMed 25257804Johnsen AT, Petersen MA, Gluud C, Lindschou J, Fayers P, Sjogren P, Pedersen L, Neergaard MA, Vejlgaard TB, Damkier A, Nielsen JB, Stromgren AS, Higginson IJ, Groenvold M. Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT). Trials. 2014 Sep 26;15:376. doi: 10.1186/1745-6215-15-376.
- Derived from this study: PubMed 32220944Skjoedt N, Johnsen AT, Sjogren P, Neergaard MA, Damkier A, Gluud C, Lindschou J, Fayers P, Higginson IJ, Stromgren AS, Groenvold M. Early specialised palliative care: interventions, symptoms, problems. BMJ Support Palliat Care. 2021 Dec;11(4):444-453. doi: 10.1136/bmjspcare-2019-002043. Epub 2020 Mar 27.
- Derived from this study: PubMed 31410598Johnsen AT, Petersen MA, Sjogren P, Pedersen L, Neergaard MA, Damkier A, Gluud C, Fayers P, Lindschou J, Stromgren AS, Nielsen JB, Higginson IJ, Groenvold M. Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients. Support Care Cancer. 2020 May;28(5):2145-2155. doi: 10.1007/s00520-019-05021-7. Epub 2019 Aug 13.
- Derived from this study: PubMed 28494643Groenvold M, Petersen MA, Damkier A, Neergaard MA, Nielsen JB, Pedersen L, Sjogren P, Stromgren AS, Vejlgaard TB, Gluud C, Lindschou J, Fayers P, Higginson IJ, Johnsen AT. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial. Palliat Med. 2017 Oct;31(9):814-824. doi: 10.1177/0269216317705100. Epub 2017 May 12.
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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.
Mogens Groenvold, MD, PhD, DMSc principal investigator
Department of Palliative Medicine, Bispebjerg Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Specialised palliative care (SPC) in people with Metastatic Cancer, run by Bispebjerg Hospital at 6 sites in Denmark.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (time frame: Baseline, 3 weeks and 8 weeks). 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 NCT01348048, which also lists 5 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 3 Mar 2015.