Examining Early Palliative Care in Newly Diagnosed Cancer Patients

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Combination Product: Standard oncological care; Combination Product: Palliative care

• Registration Number: NCT03712436
• Lead Sponsor: Yale University

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.

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 Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-19
• Primary Completion: 2020-03-15
• Study Completion: 2020-08-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Patients with any newly diagnosed cancer who are ambulatory and able to respond verbally to questions, are eligible for inclusion.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients receiving standard oncological care	Standard oncological care	Patients receiving standard oncologic care.
patients receiving palliative care	Palliative care	Patients receiving standard oncologic care plus palliative care.

Primary Outcome Measures

Name	Time	Method
African Palliative Care Association Palliative Outcome Scale (APCA POS) score	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

Name	Time	Method
Hospital Anxiety and Depression Score (HADS)	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.

Trial Locations

Locations (1)

Black Lion Hospital Oncology Clinic; 🇪🇹 Addis Ababa, Ethiopia