Examining Early Palliative Care in Newly Diagnosed Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712436
• Other study ID #: 2000023057
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cancer

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

External Links

•   APCA POS
•   HADS