Examining Early Palliative Care in Newly Diagnosed Cancer Patients

• ClinicalTrials.gov Identifier: NCT03712436
• Recruitment Status: Completed
• First Posted: October 19, 2018
• Last Update Posted: April 1, 2021
• Sponsor: Yale University
• Collaborator: Addis Ababa University
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Combination Product: Palliative care; Combination Product: Standard oncological care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
• Masking: Double (Participant, Care Provider)
• Masking Description: blinded
• Primary Purpose: Supportive Care
• Official Title: A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: March 15, 2020
• Actual Study Completion Date: August 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. African Palliative Care Association Palliative Outcome Scale (APCA POS) score [ Time Frame: 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.
2. African Palliative Care Association Palliative Outcome Scale (APCA POS) score [ Time Frame: 12 weeks ]
   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.

Secondary Outcome Measures :

1. Hospital Anxiety and Depression Score (HADS) [ Time Frame: upon enrollment ]
   HADS score measures anxiety and depression on a scale of 0-3 (best to worst). We will measure at baseline.
2. Hospital Anxiety and Depression Score (HADS) [ Time Frame: 12 weeks ]
   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.

Other Outcome Measures:

1. Healthcare Usage [ Time Frame: upon enrollment ]
   Evaluating the direct costs of all medical care,
2. Healthcare Usage [ Time Frame: 8 weeks ]
   Evaluating the direct costs of all medical care.
3. Patient reported costs [ Time Frame: 12 weeks ]
   Change in patient reported costs

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Ethiopia

Black Lion Hospital Oncology Clinic

Addis Ababa, Ethiopia

Sponsors and Collaborators

Yale University

Addis Ababa University

Investigators

• Principal Investigator: Eleanor Reid, MD; Yale University

More Information

Additional Information:

HADS 

APCA POS 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03712436
• Other Study ID Numbers: 2000023057
• First Posted: October 19, 2018
• Last Update Posted: April 1, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

Palliative Care; Supportive Care; Low Income Setting; LMIC; Africa