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Early Integration of Palliative Care in Esophageal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02547142
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : February 15, 2018
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

Brief Summary:

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.

Condition or disease Intervention/treatment
Esophageal Cancer Other: Early Palliative Care

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Implementation of an Early Integrated Palliative Care Program in the Esophageal Cancer Population
Actual Study Start Date : January 18, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547142

Contact: Christian J Finley, MD MPH FRCSC 905-522-1155 ext 33556 finleyc@mcmaster.ca
Contact: Laura Schneider, MSc 905-522-1155 ext 35877 lschnei@mcmaster.ca

Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Sub-Investigator: Wael C Hanna, MDCM MBA FRCSC FCCP         
Sub-Investigator: Yaron Shargall, MD FRCSC FCCP         
Principal Investigator: Christian Finley, MD MPH FRCSC         
Sub-Investigator: Colin Schieman, MD FRCSC         
Sub-Investigator: Anne Boyle, MD         
Sub-Investigator: Forough Farrokhyar, PhD         
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Principal Investigator: Christian Finley, MD MPH FRCSC McMaster University

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02547142     History of Changes
Other Study ID Numbers: SJHH_EarlyPalliativeCare_EDAP
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
Prospective Pre-Post Evaluation
Early Palliative care
FACT-E questionnaire
HADS questionnaire
Patient Health Questionnaire-9 (PHQ-9)

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases