Life-limiting Cancer With Prognosis of Approximately 1 YearIPaCNCT01865396
Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
A study testing Interventional palliative care and Standard oncologic care in people with Life-limiting Cancer With Prognosis of Approximately 1 Year, run by University Ghent at 1 site in Belgium.
Trial summary
The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Life-limiting Cancer With Prognosis of Approximately 1 Year
- What is being tested?
- Interventional palliative care and Standard oncologic care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Apr 2017
- 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
- Patients with life-limiting cancer (prognosis of approximately 1 year) are eligible if:
- Patients are within 12 weeks of referral from an other hospital after receiving first line treatment or within 8 to 12 weeks of a new diagnosis (histological and cytological confirmed):
- Metastatic and advanced pancreatic, stomach, oesophageal and biliary tract adenocarcinoma;
- Metastatic or advanced NSCLC (stage IIIB or IV) or metastatic SCLC,
- Malignant pleural mesothelioma
- Metastatic or advanced head and neck cancer (stage III or IV)
Show all 14Show fewer
- Patients are within 12 weeks of progression after receiving treatment and have an prognosis of approximately 1 year:
- Metastatic and locally advanced colorectal cancer, with progression after second line treatment
- Metastatic or advanced prostate carcinoma, after second line treatment
- Advanced breast cancer with visceral and/or brain metastasis, with progression on second or third line treatment
- Metastatic melanoma,
- Metastatic or advanced kidney cancer,
- Metastatic or advanced bladder cancer after first line treatment,
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and ability to read and respond to questions in Dutch.
Who cannot join
- Patients under 18 years old
- Patients with impaired cognition
- Patients who met the palliative support team more then once or had a consultation within 6 months of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients.
The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care).
The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff.
- Being tested
- Interventional palliative care, Standard oncologic care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional palliative careBehavioural
Palliative support team will meet the patient soon after diagnosis of incurable disease and will meet the patient at least once a month. The patient will also receive the standard oncologic care.
Standard oncologic careBehavioural
Patients will receive standard oncologic care.
| Study group | Role | What they receive |
|---|---|---|
| early palliative care | Experimental | Interventional palliative care, after diagnosis and once a month. Receives: Behavioral: Interventional palliative care |
| Standard care | Active comparator | Patients will receive the standard oncologic care. Receives: Behavioral: Standard oncologic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of the patient and his family caregiver at baseline.
This will be measured with validated questionnaires(EORTC-QLQ C30, McGill QoL, SF-36).
Measured: at baseline
Quality of life of the patient and his family caregiver at 12 weeks.
This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).
Measured: at 12 weeks
Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks.
This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).
Measured: 6-weekly after 12 weeks
Secondary outcomes (4)
Influence of palliative care on mood and illness-understanding of patients and family caregivers at baseline.
This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).
Measured: at baseline.
Influence of palliative care on mood and illness-understanding of patients and family caregivers at 12 weeks.
This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).
Measured: at 12 weeks
Influence of palliative care on mood and illness-understanding of patients and family caregivers 6-weekly, after 12 weeks.
This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).
Measured: 6-weekly, after 12 weeks.
Influence of palliative care on the decision of physicians with regards to end-of-life-care.
This will be measured with the questionnaire for decisions wuth regards to end-of-life decision making for physicians.
Measured: after death of patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Life-limiting Cancer With Prognosis of Approximately 1 YearStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Simon Vanbelle, MD, PhD, Study director, University Hospital, GhentLuc Deliens, PhD, MD, Study chair, Vrije Universiteit Brussel and Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865396
- Sponsor's protocol ID
- 2012/865
- Acronym
- IPaC
- Status last verified
- Nov 2021
- First submitted
- 24 May 2013
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Vanbutsele G, Pardon K, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, Cocquyt V, Geboes K, Deliens L. Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol. 2018 Mar;19(3):394-404. doi: 10.1016/S1470-2045(18)30060-3. Epub 2018 Feb 3.
PubMed 29402701Vanbutsele G, Van Belle S, De Laat M, Surmont V, Geboes K, Eecloo K, Pardon K, Deliens L. The systematic early integration of palliative care into multidisciplinary oncology care in the hospital setting (IPAC), a randomized controlled trial: the study protocol. BMC Health Serv Res. 2015 Dec 15;15:554. doi: 10.1186/s12913-015-1207-3.
PubMed 26666301
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01865396
- Acronym / sponsor ID
- IPaC / 2012/865
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Fund for Scientific Research, Flanders, Belgium
- Study start
- Apr 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 May 2013 (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.
The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients.
The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care).
The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early palliative care | Experimental | Behavioral: Interventional palliative careInterventional palliative care, after diagnosis and once a month. |
| Standard care | Active comparator | Behavioral: Standard oncologic carePatients will receive the standard oncologic care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients are within 12 weeks of referral from an other hospital after receiving first line treatment or within 8 to 12 weeks of a new diagnosis (histological and cytological confirmed):
- Patients are within 12 weeks of progression after receiving treatment and have an prognosis of approximately 1 year:
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and ability to read and respond to questions in Dutch.
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Patients with impaired cognition
- Patients who met the palliative support team more then once or had a consultation within 6 months of inclusion.
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 |
|---|---|---|
| Interventional palliative carePalliative support team will meet the patient soon after diagnosis of incurable disease and will meet the patient at least once a month. The patient will also receive the standard oncologic care. | Behavioural | early palliative care |
| Standard oncologic carePatients will receive standard oncologic care. | Behavioural | Standard care |
Primary outcome
Quality of life of the patient and his family caregiver at baseline.
Time frame: at baseline
This will be measured with validated questionnaires(EORTC-QLQ C30, McGill QoL, SF-36).
Quality of life of the patient and his family caregiver at 12 weeks.
Time frame: at 12 weeks
This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).
Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks.
Time frame: 6-weekly after 12 weeks
This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).
4 secondary outcomes
Influence of palliative care on mood and illness-understanding of patients and family caregivers at baseline.
Time frame: at baseline.
Influence of palliative care on mood and illness-understanding of patients and family caregivers at 12 weeks.
Time frame: at 12 weeks
Influence of palliative care on mood and illness-understanding of patients and family caregivers 6-weekly, after 12 weeks.
Time frame: 6-weekly, after 12 weeks.
Influence of palliative care on the decision of physicians with regards to end-of-life-care.
Time frame: after death of patient
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 1 Dec 2021.
- Derived from this study: PubMed 29402701Vanbutsele G, Pardon K, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, Cocquyt V, Geboes K, Deliens L. Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol. 2018 Mar;19(3):394-404. doi: 10.1016/S1470-2045(18)30060-3. Epub 2018 Feb 3.
- Derived from this study: PubMed 26666301Vanbutsele G, Van Belle S, De Laat M, Surmont V, Geboes K, Eecloo K, Pardon K, Deliens L. The systematic early integration of palliative care into multidisciplinary oncology care in the hospital setting (IPAC), a randomized controlled trial: the study protocol. BMC Health Serv Res. 2015 Dec 15;15:554. doi: 10.1186/s12913-015-1207-3.
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.
Simon Vanbelle, MD, PhD study director
University Hospital, Ghent
Luc Deliens, PhD, MD study chair
Vrije Universiteit Brussel and Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional palliative care and Standard oncologic care in people with Life-limiting Cancer With Prognosis of Approximately 1 Year, run by University Ghent at 1 site in Belgium.
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 14 inclusion and 3 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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
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?
Quality of life of the patient and his family caregiver at baseline. (time frame: at baseline). The study lists 3 primary outcomes in all. 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 NCT01865396, which also lists 2 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 1 Dec 2021.