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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
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

August 28, 2015
September 11, 2015
February 15, 2018
January 18, 2016
December 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02547142 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • 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
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Early Integration of Palliative Care in Esophageal Cancer Patients
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Esophageal Cancer
Other: Early Palliative Care
Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care
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.
Intervention: Other: Early Palliative Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
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
 
 
NCT02547142
SJHH_EarlyPalliativeCare_EDAP
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
McMaster University
McMaster University
St. Joseph's Healthcare Hamilton
Principal Investigator: Christian Finley, MD MPH FRCSC McMaster University
McMaster University
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP