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Examining Early Palliative Care in Newly Diagnosed Cancer Patients

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ClinicalTrials.gov Identifier: NCT03712436
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Addis Ababa University
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 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
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712436


Contacts
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Contact: Eleanor Reid, MD 203-785-2353 eleanor.reid@yale.edu

Sponsors and Collaborators
Yale University
Addis Ababa University
Investigators
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Principal Investigator: Eleanor Reid, MD Yale University

Additional Information:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03712436     History of Changes
Other Study ID Numbers: EReid.07.05.18
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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