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Active, Not Recruiting

NCT Number: NCT01248624

Randomized Controlled Trial of Early Palliative Care for Patients With Advanced Cancer

Patients with advanced cancer often have numerous physical and psychological symptoms, which can negatively affect their quality of life. A palliative care team of different health care professionals (including doctors, nurses, social workers and therapists) specializes in treating these symptoms and offers support for patients and their families. However, palliative care teams are currently involved only in the last two months of a patient's life or not at all.

The main purpose of this study is to determine whether, compared to conventional cancer care, early involvement by a specialized symptom control and palliative care team in patients with advanced cancer will be associated with: better quality of life, greater patient and caregiver satisfaction with care, better symptom control, improved communication with healthcare providers and improved caregiver quality of life.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

Twenty-four cancer outpatient clinics at Princess Margaret Hospital, Toronto have been randomly assigned so that patients attending them will receive either early palliative care (referral to the palliative care team) or routine cancer care.

Patients are recruited from Gastrointestinal, Lung, Genitourinary, Gynecology and Breast clinics and are eligible to participate if they have advanced cancer, and have a life expectancy of six months to two years.

Patients and their caregivers who agree to participate are asked to complete questionnaires at baseline and every month for 4 months. These questionnaires ask about their quality of life, and satisfaction with their medical care. After they have completed the 4-month questionnaires, some patients and their caregivers will be interviewed, so that they can describe in their own words their quality of life, satisfaction with care, and views about palliative care. These interviews will be audiotaped and analyzed to provide additional information that cannot be obtained by questionnaires alone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Dx of stage IV cancer (metastatic); refractory to hormonal therapy for breast or prostate cancer; stage III or IV for lung cancer.
  • ECOG performance status ≤ 2 (estimated by primary oncologist)
  • Prognosis of >6 months to 2 years (estimated by primary oncologist)

Exclusion criteria

  • Insufficient English literacy to complete questionnaires
  • Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score <20 or >10 errors)

Treatment and study plan

Early Palliative Care Referral

Behavioral

The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.

Primary outcomes

  1. Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.

    Time frame: Three months after enrollment.

    Together, the FACT-G (Functional Assessment of Cancer Therapy-General), QUAL-E (Quality of Life at the End of Life), and FACIT-Sp ('Meaning and Peace' and 'Faith' subscales) measure physical, social/family, emotional, functional and existential well-being.

Secondary outcomes

  1. Symptom control (patient outcome).

    Time frame: Three months after enrollment.

    The patient outcome of 'symptom control' is measured by the ESAS (Edmonton Symptom Assessment System).

  2. Communication with healthcare providers (patient outcome).

    Time frame: 3 months after enrollment.

    Patient communication with healthcare providers is measured by the CARES (Medical Interaction Subscale).

  3. Patient and caregiver satisfaction with care.

    Time frame: 3 months after enrollment.

    The outcome of 'satisfaction with care' is measured by the FAMCARE (Family Satisfaction with Cancer Scale) for primary caregivers. Patients complete a modified version of the FAMCARE scale.

  4. Caregiver quality of life (caregiver outcome).

    Time frame: 3 months after enrollment.

    Caregiver quality of life is measured by Caregiver Quality of Life Index-Cancer (CQOL-C) and the SF-36 (Caregiver Health and Functioning Medical Outcomes Study Short-form).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial

Important dates

Study start
2006
Primary completion
2011
Study completion
2027
First posted
Nov 25, 2010
Registry last updated
Jun 26, 2025

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.

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