Examining Early Palliative Care in Newly Diagnosed Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia

Conditions
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Cancer

Intervention / Treatment
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* Combination Product: Palliative care
* Combination Product: Standard oncological care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients receiving palliative care<br>Patients receiving standard oncologic care plus palliative care. | Combination Product: Palliative care<br>* 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.<br>|
| Active Comparator: patients receiving standard oncological care<br>Patients receiving standard oncologic care. | Combination Product: Standard oncological care<br>* Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| African Palliative Care Association Palliative Outcome Scale (APCA POS) score | 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. | upon enrollment | 
| African Palliative Care Association Palliative Outcome Scale (APCA POS) score | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Score (HADS) | HADS score measures anxiety and depression on a scale of 0-3 (best to worst). We will measure at baseline. | upon enrollment | 
| Hospital Anxiety and Depression Score (HADS) | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Supportive Care, Low Income Setting, LMIC, Africa