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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865396
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : December 1, 2021
Sponsor:
Collaborators:
Vrije Universiteit Brussel
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Ghent

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Life-limiting Cancer With Prognosis of Approximately 1 Year Behavioral: Interventional palliative care Behavioral: Standard oncologic care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
Study Start Date : April 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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Arm Intervention/treatment
Experimental: early palliative care
Interventional palliative care, after diagnosis and once a month.
 Behavioral: 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.
Active Comparator: Standard care
Patients will receive the standard oncologic care.
 Behavioral: Standard oncologic care
Patients will receive standard oncologic care.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Influence of palliative care on mood and illness-understanding of patients and family caregivers at baseline. [ Time Frame: at baseline. ]
    This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

  2. Influence of palliative care on mood and illness-understanding of patients and family caregivers at 12 weeks. [ Time Frame: at 12 weeks ]
    This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

  3. 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. ]
    This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

  4. Influence of palliative care on the decision of physicians with regards to end-of-life-care. [ Time Frame: after death of patient ]
    This will be measured with the questionnaire for decisions wuth regards to end-of-life decision making for physicians.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865396


Locations
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Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Vrije Universiteit Brussel
Fund for Scientific Research, Flanders, Belgium
Investigators
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Study Director: Simon Vanbelle, MD, PhD University Hospital, Ghent
Study Chair: Luc Deliens, PhD, MD Vrije Universiteit Brussel and Ghent University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01865396    
Other Study ID Numbers: 2012/865
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021