NCT05314179

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

March 28, 2022

Last Update Submit

July 19, 2025

Conditions

Keywords

doula

Outcome Measures

Primary Outcomes (2)

  • Change in Integrated Palliative care Outcome Scale (IPOS)

    IPOS (Integrated Palliative care Outcome Scale) is a measure of symptoms and concerns which matter to a patient and helps us provide the best care. IPOS forms to identify how we can best support the individual. There are 10 questions scored on a scale of 1-4, which assess a patient's symptoms and needs with regards to physical, social, psychological and spiritual. Higher scores indicate greater patient need for supportive care.

    Baseline, 3 months and 6 months

  • Acceptability and feasibility of the Doula Program

    Acceptability and feasibility of doula program will be assessed by the Evaluation of the UPP Program questionnaire, which is comprised of 7 questions that will be used to rate participant satisfaction with the Doula Program that employ a scale of 1 (not at all) to 10 (to a great degree). Higher overall scores indicate greater satisfaction with the program.

    Up to 6 months

Study Arms (1)

Doula-Patient engagement

EXPERIMENTAL

Four hours/week of Ubuntu ambassador/Doula and Patient engagement. The nature and type of visits will be determined by the patient and doula. The doula will formulate weekly reports for each assigned patient. Weekly progress reporting - Weeks 2- 24.

Behavioral: Doula - Patient engagement

Interventions

Ubuntu ambassador/Doula and Patient will decide on details of engagement. The components to be included will be: 1) emotional support, 2) practical assistance, 3) family support, and/or 4) legacy building projects as per study protocols. The nature and type of visits will be determined by the patient and doula.

Doula-Patient engagement

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Do not live in the Pittsburgh region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret Quinn Rosenzweig, PhD

    UPMC Hillman Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pre and post intervention pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 6, 2022

Study Start

March 13, 2022

Primary Completion

July 2, 2025

Study Completion

July 2, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations