Examining Early Palliative Care in Newly Diagnosed Cancer Patients

Yale University98 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cancer

Interventions

Palliative careCOMBINATION_PRODUCT

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 careCOMBINATION_PRODUCT

Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Black Lion Hospital Oncology Clinic

Addis Ababa, Ethiopia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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