Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving palliative care | Experimental | Patients receiving standard oncologic care plus palliative care. |
|
| patients receiving standard oncological care | Active Comparator | Patients receiving standard oncologic care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative care | Combination Product | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Usage | Evaluating the direct costs of all medical care, | upon enrollment |
| Healthcare Usage | Evaluating the direct costs of all medical care. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eleanor Reid, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Black Lion Hospital Oncology Clinic | Addis Ababa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32309673 | Derived | Reid E, Abathun E, Diribi J, Mamo Y, Hall P, Fallon M, Wondemagegnhu T, Grant L. Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia. Contemp Clin Trials Commun. 2020 Apr 6;18:100564. doi: 10.1016/j.conctc.2020.100564. eCollection 2020 Jun. |
| Label | URL |
|---|---|
| HADS | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
Not provided
Not provided
blinded
| Standard oncological care | Combination Product | Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology |
|
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 |
| 8 weeks |
| Patient reported costs | Change in patient reported costs | 12 weeks |
| APCA POS | View source |