Metastatic CancerNCT05314179
Ubuntu - I Am Because We Are
A study testing Doula - Patient engagement in people with Metastatic Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Doula - Patient engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2022to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have stage IV cancer
- identify as Black or African American 3. Participants must reside in or around Pittsburgh, Pennsylvania area
Who cannot join
- 1. Do not live in the Pittsburgh region
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Ubuntu - I Am Because We Are, Caring for Black Patients With Advanced Stage Cancer
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.
Read the 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
- 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,
- to help the individual recognize their unique legacy,
- 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.
- Conditions
- Metastatic Cancer
- Being tested
- Doula - Patient engagement
- Keywords
- doula
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula - Patient engagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Doula - Patient engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start13 Mar 2022
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre and post intervention pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Quinn Rosenzweig, University of Pittsburgh
- Investigators
- Margaret Quinn Rosenzweig, PhD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314179
- Sponsor's protocol ID
- HCC 21-265
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ubuntu - I Am Because We Are, Caring for Black Patients With Advanced Stage Cancer
- ClinicalTrials.gov ID
- NCT05314179
- Acronym / sponsor ID
- HCC 21-265
- Conditions
- Metastatic Cancer
- Keywords
- doula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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,
- to help the individual recognize their unique legacy,
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre and post intervention pilot study
| Arm | Type | Receives |
|---|---|---|
| Doula-Patient engagement | Experimental | Behavioral: Doula - Patient engagementFour 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have stage IV cancer
- identify as Black or African American 3. Participants must reside in or around Pittsburgh, Pennsylvania area
Key exclusion criteria (1 listed)
- 1. Do not live in the Pittsburgh region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula - Patient engagementUbuntu 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. | Behavioural | Doula-Patient engagement |
Primary outcome
Change in Integrated Palliative care Outcome Scale (IPOS)
Time frame: Baseline, 3 months and 6 months
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.
Acceptability and feasibility of the Doula Program
Time frame: Up to 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Quinn Rosenzweig, PhD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula - Patient engagement in people with Metastatic Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Integrated Palliative care Outcome Scale (IPOS) (time frame: Baseline, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.