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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Ghent
Sponsor:
Collaborators:
Vrije Universiteit Brussel
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01865396
First received: May 24, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention
Life-limiting Cancer With Prognosis of Approximately 1 Year
Behavioral: Interventional palliative care
Behavioral: Standard oncologic care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Quality of life of the patient and his family caregiver at baseline. [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).


Secondary Outcome Measures:
  • Influence of palliative care on mood and illness-understanding of patients and family caregivers at baseline. [ Time Frame: at baseline. ] [ Designated as safety issue: No ]
    This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

  • Influence of palliative care on mood and illness-understanding of patients and family caregivers at 12 weeks. [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

  • 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. ] [ Designated as safety issue: No ]
    This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

  • Influence of palliative care on the decision of physicians with regards to end-of-life-care. [ Time Frame: after death of patient ] [ Designated as safety issue: No ]
    This will be measured with the questionnaire for decisions wuth regards to end-of-life decision making for physicians.


Estimated Enrollment: 160
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865396

Contacts
Contact: Gaëlle Vanbutsele 09/332 07 92 gaelle.vanbutsele@uzgent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Gaëlle Vanbutsel       gaelle.vanbutsel@uzgent.be   
Principal Investigator: Gaëlle Vanbutsele         
Sponsors and Collaborators
University Ghent
Vrije Universiteit Brussel
Fund for Scientific Research, Flanders, Belgium
Investigators
Study Director: Simon Vanbelle, MD, PhD Ghent University Hospital
Study Chair: Luc Deliens, PhD, MD Vrije Universiteit Brussel and Ghent University
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01865396     History of Changes
Other Study ID Numbers: 2012/865
Study First Received: May 24, 2013
Last Updated: March 25, 2014
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on October 20, 2014