Examining Early Palliative Care in Newly Diagnosed Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Combination product: Palliative care; Combination product: Standard oncological care

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Black Lion Hospital Oncology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patients receiving palliative care; Patients receiving standard oncologic care plus palliative care.	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.
ACTIVE_COMPARATOR: patients receiving standard oncological care; Patients receiving standard oncologic care.	Combination product: Standard oncological care; Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	8 weeks
Patient reported costs	Change in patient reported costs	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Addis Ababa University
• Investigators: Principal Investigator: Eleanor Reid, MD, Yale University

Publications and helpful links

General Publications

• 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.

Helpful Links

• HADS
• APCA POS

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): August 15, 2020

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (ACTUAL): October 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Palliative Care; Supportive Care; Africa; LMIC; Low Income Setting
• Other Study ID Numbers: 2000023057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No