Clinical trial NCT03712436: Examining Early Palliative Care in Newly Diagnosed Cancer Patients
Official title: A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Palliative Care
Supportive Care
Low Income Setting
LMIC
Africa
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
First posted: 2018-10-19
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: African Palliative Care Association Palliative Outcome Scale (APCA POS) score
timeFrame: upon enrollment
measure: African Palliative Care Association Palliative Outcome Scale (APCA POS) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Score (HADS)
timeFrame: upon enrollment
measure: Hospital Anxiety and Depression Score (HADS)
timeFrame: 12 weeks
Other outcomes:
measure: Healthcare Usage
timeFrame: upon enrollment
measure: Healthcare Usage
timeFrame: 8 weeks
measure: Patient reported costs
timeFrame: 12 weeks
Locations:
city: Addis Ababa
country: Ethiopia
facility: Black Lion Hospital Oncology Clinic
Study officials:
affiliation: Yale University
name: Eleanor Reid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.