NCT02547142

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

August 28, 2015

Last Update Submit

March 12, 2019

Conditions

Esophageal Cancer

Keywords

Prospective Pre-Post EvaluationEarly Palliative careFACT-E questionnaireHADS questionnairePatient Health Questionnaire-9 (PHQ-9)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Esophageal cancer-specific symptom score

    As reported by questionnaire at 12 weeks after study consent

  • Esophageal cancer-specific symptom management score

    As reported by questionnaire at 12 weeks after study consent

  • Anxiety Score

    As reported by questionnaire at 12 weeks after study consent

  • Depression 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 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

Study Arms (1)

Early Palliative Care Group

EXPERIMENTAL

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

Interventions

Early Palliative CareOTHER

Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care

Early Palliative Care Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Christian Finley, MD MPH FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 11, 2015

Study Start

January 18, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)