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Early Integration of Palliative Care in Esophageal Cancer Patients

Primary Purpose

Esophageal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early Palliative Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophageal Cancer focused on measuring Prospective Pre-Post Evaluation, Early Palliative care, FACT-E questionnaire, HADS questionnaire, Patient Health Questionnaire-9 (PHQ-9)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early Palliative Care Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Quality Of Life
Change in perceived quality of life as reported by esophageal cancer patients.

Secondary Outcome Measures

Esophageal cancer-specific symptom score
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.
Esophageal cancer-specific symptom management score
The Patient Health Questionnaire (PHQ-9) will be used to measure the impact of the intervention on patient symptom management
Anxiety Score
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
Depression Score
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
Total duration of time from date of metastatic diagnosis to date of death
Patient survival post metastatic esophageal cancer diagnosis

Full Information

First Posted
August 28, 2015
Last Updated
March 12, 2019
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02547142
Brief Title
Early Integration of Palliative Care in Esophageal Cancer Patients
Official Title
Evaluation of the Implementation of an Early Integrated Palliative Care Program in the Esophageal Cancer Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Study futility with regards to recruitment
Study Start Date
January 18, 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Prospective Pre-Post Evaluation, Early Palliative care, FACT-E questionnaire, HADS questionnaire, Patient Health Questionnaire-9 (PHQ-9)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Palliative Care Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early Palliative Care
Intervention Description
Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care
Primary Outcome Measure Information:
Title
Quality Of Life
Description
Change in perceived quality of life as reported by esophageal cancer patients.
Time Frame
As reported by questionnaire at 12 weeks after study consent
Secondary Outcome Measure Information:
Title
Esophageal cancer-specific symptom score
Description
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.
Time Frame
As reported by questionnaire at 12 weeks after study consent
Title
Esophageal cancer-specific symptom management score
Description
The Patient Health Questionnaire (PHQ-9) will be used to measure the impact of the intervention on patient symptom management
Time Frame
As reported by questionnaire at 12 weeks after study consent
Title
Anxiety Score
Description
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
Time Frame
As reported by questionnaire at 12 weeks after study consent
Title
Depression Score
Description
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
Time Frame
As reported by questionnaire at 12 weeks after study consent
Title
Total duration of time from date of metastatic diagnosis to date of death
Description
Patient survival post metastatic esophageal cancer diagnosis
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Finley, MD MPH FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Integration of Palliative Care in Esophageal Cancer Patients

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