Early Integration of Palliative Care in Esophageal Cancer Patients

March 12, 2019 updated by: McMaster University

Evaluation of the Implementation of an Early Integrated Palliative Care Program in the Esophageal Cancer Population

Palliative care physicians and nurses are trained to help reduce suffering and improve quality of life in patients under their care. Their services also include other components such as referral to dietitians, social workers and community resources, to assist patients in their homes. In addition to this, they may also administer interventions to make patients more comfortable, assisting them and their families in making important decisions and providing support, during that time.

At present, palliative care is provided to esophageal cancer patients on an as-needed basis, through the referral of a heath care professional or the patient's request. This study aims to assess the impact of the integration of early palliative care combined with appropriate medical care in the metastatic esophageal cancer population, so that patients can benefit from these services at an earlier stage. It is hoped that this will improve quality of life, symptom management, depression and anxiety, as well as survival.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Previous reports suggest that starting palliative care early in patients with breast, colorectal, prostate and lung cancers appear to improve quality of life, symptom management, depression, anxiety and perhaps even survival, but it has never been tested in patients with esophageal cancer.This study aims to assess the impact of the introduction of early palliative care services on the esophageal cancer population, as opposed to traditional palliative care, which is provided on an as-needed basis, usually in end-of-life situations.

The study is a prospective one-armed pre-post intervention evaluation. Eligible patients that have consented will receive an early consultation with the palliative care group. In addition to this, the patients will be administered appropriate oncological care including surgical, brachytherapy, chemotherapy or radiotherapy services. The patients will be referred to the palliative service at the time of consent, with a consultation taking place within one week of referral receipt. The nurses and physicians involved in the palliative service will not only provide symptom management, psychosocial support, assistance with treatment related decisions and other patient needs. Information about symptoms, anxiety and depression, and quality of life will be collected through surveys at two timepoints - at baseline, when the patient consents and at 12 weeks post diagnosis of metastatic disease. The primary outcome of the study is the change in quality of life perceived by esophageal cancer patients at the two timepoints. Secondary outcomes include differences in esophageal cancer specific symptoms and anxiety and depression scores at the two timepoints, as well as patient survival information.

This study is integrated into the currently operational Esophageal Diagnostic Assessment Program (EDAP) conceptualized and implemented at St. Joseph's Healthcare Hamilton. It is hoped that this study will also help to establish the full integration of palliative care into the overall care of patients with esophageal cancer.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients newly diagnosed or referred to the Esophageal Diagnostic Assessment Program (EDAP) program with suspicious findings found to be esophageal cancer AND
  • Patients who present with metastatic disease, defined as N3 lymph node involvement or distant metastatic deposits as confirmed on PET scan
  • Patients must have been notified by a member of their healthcare team of their prognosis and palliative categorization as noted in the patient chart within 8 weeks of diagnosis
  • Patients may undergo esophagectomy, stenting, brachytherapy or palliative intent chemotherapy or radiotherapy as clinically indicated

Exclusion Criteria:

  • Individuals unable to complete questionnaires with assistance
  • Patients presently undergoing neoadjuvant chemotherapy or radiotherapy for malignancy
  • Patients with recurrent esophageal cancer
  • Patients who are referred back to EDAP for restaging after completing neoadjuvant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Palliative Care Group
This is the intervention group and will consist of patients that have been randomized into the early palliative group, with a consultation expected to take place within one week of randomization. Patients in this group will still receive appropriate guideline based oncologic care including any surgical, brachytherapy, chemotherapy or radiotherapy services, along with palliative services.
Other: Early Palliative Care
Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality Of Life
Time Frame: As reported by questionnaire at 12 weeks after study consent
Change in perceived quality of life as reported by esophageal cancer patients.
As reported by questionnaire at 12 weeks after study consent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal cancer-specific symptom score
Time Frame: As reported by questionnaire at 12 weeks after study consent
Reported using the Functional Assessment of Cancer Therapy-Esophagus (FACT-E) tool - includes physical well-being, social/family well-being, emotional well-being, functional well-being, and symptom-specific measures. Scores range from 0 (not at all) to 4 (very much), and assesses how severely the symptom affects patients.
As reported by questionnaire at 12 weeks after study consent
Esophageal cancer-specific symptom management score
Time Frame: As reported by questionnaire at 12 weeks after study consent
The Patient Health Questionnaire (PHQ-9) will be used to measure the impact of the intervention on patient symptom management
As reported by questionnaire at 12 weeks after study consent
Anxiety Score
Time Frame: As reported by questionnaire at 12 weeks after study consent
Anxiety scores reported on the Hospital Anxiety and Depression Scale (HADS) Scale. The scores are summed to obtain a "normal", "borderline abnormal" or "abnormal" score
As reported by questionnaire at 12 weeks after study consent
Depression Score
Time Frame: As reported by questionnaire at 12 weeks after study consent
Depression scores reported on the Hospital Anxiety and Depression Scale (HADS) Scale. The scores are summed to obtain a "normal", "borderline abnormal" or "abnormal" score
As reported by questionnaire at 12 weeks after study consent
Total duration of time from date of metastatic diagnosis to date of death
Time Frame: Time difference between date of diagnosis to the confirmed date of death as noted in patient medical records, assessed up to 60 months after the date of metastatic diagnosis
Patient survival post metastatic esophageal cancer diagnosis
Time difference between date of diagnosis to the confirmed date of death as noted in patient medical records, assessed up to 60 months after the date of metastatic diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Christian Finley, MD MPH FRCSC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJHH_EarlyPalliativeCare_EDAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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