Early Integration of Palliative Care in Esophageal Cancer Patients

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02547142
• Other study ID #: SJHH_EarlyPalliativeCare_EDAP
• Status: Terminated
• Phase: N/A
• Start date: January 18, 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• Early Palliative Care
Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality Of Life	Change in perceived quality of life as reported by esophageal cancer patients.	As reported by questionnaire at 12 weeks after study consent
Secondary	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.	As reported by questionnaire at 12 weeks after study consent
Secondary	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	As reported by questionnaire at 12 weeks after study consent
Secondary	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	As reported by questionnaire at 12 weeks after study consent
Secondary	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	As reported by questionnaire at 12 weeks after study consent
Secondary	Total duration of time from date of metastatic diagnosis to date of death	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