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Completed

NCT Number: NCT03712436

Examining Early Palliative Care in Newly Diagnosed Cancer Patients

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Black Lion Hospital Oncology Clinic

Addis Ababa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palliative care

Combination 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 care

Combination Product

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Addis Ababa University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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