Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.

Conditions
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Life-limiting Cancer With Prognosis of Approximately 1 Year

Intervention / Treatment
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* Behavioral: Interventional palliative care
* Behavioral: Standard oncologic care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early palliative care<br>Interventional palliative care, after diagnosis and once a month. | Behavioral: Interventional palliative care<br>* 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.<br>|
| Active Comparator: Standard care<br>Patients will receive the standard oncologic care. | Behavioral: Standard oncologic care<br>* Patients will receive standard oncologic care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 6-weekly after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | after death of patient |