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

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 Overview

• Status: Completed
• Conditions: Life-limiting Cancer With Prognosis of Approximately 1 Year
• Intervention / Treatment: Behavioral: Interventional palliative care; Behavioral: Standard oncologic care

• Study Type: Interventional
• Enrollment (Actual): 268
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Vrije Universiteit Brussel; Fund for Scientific Research, Flanders, Belgium
• Investigators: Study Director: Simon Vanbelle, MD, PhD, University Hospital, Ghent; Study Chair: Luc Deliens, PhD, MD, Vrije Universiteit Brussel and Ghent University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): May 30, 2013

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2012/865