Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
NCT ID: NCT01865396
Last Updated: 2021-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
268 participants
INTERVENTIONAL
2013-04-30
2017-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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early palliative care
Interventional palliative care, after diagnosis and once a month.
Interventional palliative care
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 care
Patients will receive the standard oncologic care.
Standard oncologic care
Patients will receive standard oncologic care.
Interventions
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Interventional palliative care
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 care
Patients will receive standard oncologic care.
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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.
Exclusion Criteria
* Patients with impaired cognition
* Patients who met the palliative support team more then once or had a consultation within 6 months of inclusion.
18 Years
ALL
No
Sponsors
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Vrije Universiteit Brussel
OTHER
Fund for Scientific Research, Flanders, Belgium
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Simon Vanbelle, MD, PhD
Role: STUDY_DIRECTOR
University Hospital, Ghent
Luc Deliens, PhD, MD
Role: STUDY_CHAIR
Vrije Universiteit Brussel and Ghent University
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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References
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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.
Vanbutsele 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.
Other Identifiers
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2012/865
Identifier Type: -
Identifier Source: org_study_id