Clinical trial NCT05314179: Ubuntu - I Am Because We Are
Official title: Ubuntu - I Am Because We Are, Caring for Black Patients With Advanced Stage Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Keywords: doula
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre and post intervention pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The program will provide Advocacy and Support for Black patients with advanced-stage cancer in the Pittsburgh area. The goals are to: 1) provide a community-based, trained companion to journey alongside the patient with advanced cancer, 2) to help the individual explore meaning and create legacy, 3); offer support and navigation for practical needs of illness (e.g., financial assistance for food and housing, accessing and affording medications, transportation); and 4) to provide support and connection for the bereaved family/friends, including facilitating community connections for routine health screenings and access to mental health services, as needed.

Detailed description: Across almost all types of cancer, Black patients experience shorter survival and disproportionate burdens of isolation, pain, financial toxicity, and symptom distress at the end of life. The importance of palliative care in providing patient-centered treatment plans that alleviate symptom burden and provide goal-concordant care is well-established; however, Black patients have been historically reluctant to utilize traditional palliative care and hospice services despite efforts on the part of the largely white palliative care community to increase their utilization. This proposed program provides a non-medically focused program to assist Black patients living with advanced cancer. Black individuals are less likely to discuss their end-of-life (EOL) plans before death (1), engage in advanced care planning, use hospice (2), and are more likely to undergo intensive treatment in the last months of life (2-4), limiting the ability of the patient and family to receive an end of life support and create a legacy. Low-income black individuals have additional practical needs for food, housing, transportation, and medication assistance exacerbated by the advanced illness often overwhelming the traditional assistance capabilities of the medical model. There is a growing need for innovation to meet the EOL care needs of Black populations and communities requiring more culturally tailored support than traditionally available from the cancer care delivery system.

The goal is to provide

1. a community-based, peer, trained, paid companion to journey alongside the patient with advanced cancer, providing support, advocacy, and acknowledgment of the fear and trauma of living with a progressive, life-ending illness,
2. to help the individual recognize their unique legacy,
3. to assist surviving family members with mental and physical health promotion. The navigators/social workers or community advocates will identify individuals/patients who are eligible for the study. If the advocate is able to be at the clinic site at the time of the appointment, they will meet with the patient to say hello if the patient agrees. They will speak to the patient/family about the program. Patients will be asked if the ambassadors can call and make the connection.

Eligibility criteria: Inclusion Criteria:

1. have stage IV cancer
2. identify as Black or African American 3. Participants must reside in or around Pittsburgh, Pennsylvania area

Exclusion Criteria:

1. Do not live in the Pittsburgh region

Primary outcomes:
measure: Change in Integrated Palliative care Outcome Scale (IPOS)
timeFrame: Baseline, 3 months and 6 months
measure: Acceptability and feasibility of the Doula Program
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: UPMC Hillman Cancer Center
name: Margaret Quinn Rosenzweig, PhD
role: PRINCIPAL_INVESTIGATOR
References: