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Completed

NCT Number: NCT01865396

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

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.

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Key information

Conditions

Life-limiting Cancer With Prognosis of Approximately 1 Year

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interventional palliative care

Behavioral

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

Behavioral

Patients will receive standard oncologic care.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium
  • Vrije Universiteit Brussel

Registry information

Acronym: IPaC

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 30, 2013
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.