Cancer
Conditions
Keywords
Palliative Care, Supportive Care, Low Income Setting, LMIC, Africa
Brief summary
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
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.
Interventions
COMBINATION_PRODUCTPalliative care
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.
COMBINATION_PRODUCTStandard oncological care
Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology
Sponsors
Addis Ababa University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
blinded
Intervention model description
A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| African Palliative Care Association Palliative Outcome Scale (APCA POS) score | upon enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Score (HADS) | upon enrollment | HADS score measures anxiety and depression on a scale of 0-3 (best to worst). We will measure at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Usage | upon enrollment | Evaluating the direct costs of all medical care, |
| Patient reported costs | 12 weeks | Change in patient reported costs |
Countries
Ethiopia
Outcome results
None listed