Examining Early Palliative Care in Newly Diagnosed Cancer Patients
March 31, 2021 updated by: Yale University
A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia
To understand the impact of initiation of palliative care in this low-resource setting, and whether palliative care is a cost-reducing intervention that will improve patient-reported outcomes and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators overall goal is to understand the impact of initiation of early palliative care in an oncology population in a low-resource setting in order to provide guidance for future public health policies surrounding the provision of palliative care in Ethiopia.
Hypothesis: The investigators hypothesize that initiation of palliative care in this low-resource setting is a cost-reducing intervention that will improve patient-reported outcomes and quality of life.
Preliminary data: This research will focus on adult patients with oncologic diagnoses as preliminary research in this setting revealed that this patient population had the highest depression and anxiety scores, the lowest palliative outcome scores, and reported the highest costs of medical care.
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Addis Ababa, Ethiopia
- Black Lion Hospital Oncology Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with any newly diagnosed cancer who are ambulatory and able to respond verbally to questions, are eligible for inclusion.
Exclusion Criteria:
- Patients who have not been diagnosed with cancer.
- Patients with diagnoses made more than 4 weeks ago, who are non-ambulatory, or are already receiving palliative care, are ineligible to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: patients receiving palliative care
Patients receiving standard oncologic care plus palliative care.
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The Palliative Care Package is a protocol for Palliative Care delivery, derived from the African Palliative Care Association and adapted to the local environment in Addis Ababa.
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ACTIVE_COMPARATOR: patients receiving standard oncological care
Patients receiving standard oncologic care.
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Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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African Palliative Care Association Palliative Outcome Scale (APCA POS) score
Time Frame: upon enrollment
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APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst).
We will measure at baseline.
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upon enrollment
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African Palliative Care Association Palliative Outcome Scale (APCA POS) score
Time Frame: 12 weeks
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APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst).
We will compare baseline score to follow up score.
An APCA POS score decrease of 3 from baseline will be signficant.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression Score (HADS)
Time Frame: upon enrollment
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HADS score measures anxiety and depression on a scale of 0-3 (best to worst).
We will measure at baseline.
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upon enrollment
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Hospital Anxiety and Depression Score (HADS)
Time Frame: 12 weeks
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HADS score measures anxiety and depression on a scale of 0-3 (best to worst).
HADS score decrease from baseline, as measured at follow up.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healthcare Usage
Time Frame: upon enrollment
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Evaluating the direct costs of all medical care,
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upon enrollment
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Healthcare Usage
Time Frame: 8 weeks
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Evaluating the direct costs of all medical care.
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8 weeks
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Patient reported costs
Time Frame: 12 weeks
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Change in patient reported costs
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eleanor Reid, MD, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2018
Primary Completion (ACTUAL)
March 15, 2020
Study Completion (ACTUAL)
August 15, 2020
Study Registration Dates
First Submitted
September 14, 2018
First Submitted That Met QC Criteria
October 16, 2018
First Posted (ACTUAL)
October 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 31, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2000023057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.