NCT03712436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

September 14, 2018

Last Update Submit

March 31, 2021

Conditions

Cancer

Keywords

Palliative CareSupportive CareLow Income SettingLMICAfrica

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 weeks

Secondary Outcomes (2)

  • Hospital Anxiety and Depression Score (HADS)

    upon enrollment

  • Hospital Anxiety and Depression Score (HADS)

    12 weeks

Other Outcomes (3)

  • Healthcare Usage

    upon enrollment

  • Healthcare Usage

    8 weeks

  • Patient reported costs

    12 weeks

Study Arms (2)

patients receiving palliative care

EXPERIMENTAL

Patients receiving standard oncologic care plus palliative care.

Combination Product: Palliative care

patients receiving standard oncological care

ACTIVE COMPARATOR

Patients receiving standard oncologic care.

Combination Product: Standard oncological care

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.

patients receiving palliative care
Standard oncological careCOMBINATION_PRODUCT

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

patients receiving standard oncological care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Lion Hospital Oncology Clinic

Addis Ababa, Ethiopia

Location

Related Publications (1)

  • 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.

    PMID: 32309673DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eleanor Reid, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

October 19, 2018

Study Start

June 1, 2018

Primary Completion

March 15, 2020

Study Completion

August 15, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)