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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03712436
Other study ID # 2000023057
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date August 15, 2020

Study information

Verified date March 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date August 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Palliative 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.
Standard oncological care
Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology

Locations

Country Name City State
Ethiopia Black Lion Hospital Oncology Clinic Addis Ababa

Sponsors (2)

Lead Sponsor Collaborator
Yale University Addis Ababa University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Other Healthcare Usage Evaluating the direct costs of all medical care, upon enrollment
Other Healthcare Usage Evaluating the direct costs of all medical care. 8 weeks
Other Patient reported costs Change in patient reported costs 12 weeks
Primary 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
Primary 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 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
Secondary 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
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