Prostate CarcinomaNCT06472817
Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men
An observational study of Prostate Carcinoma, run by Mayo Clinic at 3 sites in United States.
Trial summary
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Sep 2023to 29 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Sub-Saharan African immigrant men who were diagnosed with prostate cancer.
Who may be able to join
- PHASE I:
- Adult men originally from each of these geographic regions (East, West, Central, and Southern Africa) and have been diagnosed with prostate cancer
- Able to provide written consent and conduct an interview
- Able to speak and understand English
- PHASE II:
- Caribbean Immigrant men and SSAI men diagnosed with CaP within the last 10 years who identify as Black and speak English
- Able to provide written consent and conduct an interview
- Able to speak and understand English
Who cannot join
- PHASE I:
- Patients below the ages of 18, and those not belonging to any of four regions
- Employees of Mayo Clinic will be excluded
- Non-English speakers will not be included
- PHASE II:
- Individuals below the age of 18
Show all 9Show fewer
- Those not diagnosed with prostate cancer and individuals not from the regions described above
- Employees of Mayo Clinic will be excluded
- Non-English speakers will not be included
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Georgia State University
Atlanta, Georgia, 30302-3965
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: iCCARE Project # 4: Grounded Theory Study of the Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men Diagnosed With Prostate Cancer
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.
Read the detailed description
PRIMARY OBJECTIVE:
- To employ the social determinant of migrant health framework (International Organization for Migration, n.d.) to examine the impact of immigration on the health-seeking behaviors of SSAI including informed-decision making, psychosocial effects and coping mechanisms. (Phase I) II. To examine SDOMH factors among SSAI and CI men, including their migration experience and health behaviors. (Phase II)
OUTLINE: This is an observational study.
AIM I: Participants complete a survey and participate in an interview in person, over the phone, or via zoom on study.
AIM II: Participants complete an interview in person, over the phone, or via zoom on study.
- Conditions
- Prostate Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | AIM I: Participants complete a survey and participate in an interview in person, over the phone, or via zoom on study.
AIM II: Participants complete an interview in person, over the phone, or via zoom on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview - identification of themes and constructs
Data will be collected during an in-depth interview and will be analyzed with an inductive, open coding approach, first identifying themes, then constructs that emerge from the data will be categorized and mapped, noting new concepts and constructs. Theme convergence and divergence will be assessed. The interview guide focuses on participants' experiences and health-seeking behaviors regarding prostate cancer prevention, detection, decision-making, treatment, care, and survivorship.
Measured: Baseline
Immigrant social determinants of health factors that impact Sub-Saharan African Immigrant (SSAI) carcinoma of the prostate (CaP) survivors
From the data generated in Outcome 1 interviews, an interpretive framework or theoretical model for SSAI men will be developed to evaluate and identify factors that contribute to or exacerbate disparities in prostate cancer.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start5 Sep 2023
- Primary completion29 Sep 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Gladys B. Asiedu, Ph.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472817
- Sponsor's protocol ID
- 22-005329
- Other IDs
- NCI-2024-03996, 17109, 22-005329, W81XWH-22-1-0971
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCCARE Project # 4: Grounded Theory Study of the Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men Diagnosed With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06472817
- Acronym / sponsor ID
- 22-005329
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 25 Jun 2024 (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.
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.
Detailed description
PRIMARY OBJECTIVE:
- To employ the social determinant of migrant health framework (International Organization for Migration, n.d.) to examine the impact of immigration on the health-seeking behaviors of SSAI including informed-decision making, psychosocial effects and coping mechanisms. (Phase I) II. To examine SDOMH factors among SSAI and CI men, including their migration experience and health behaviors. (Phase II)
OUTLINE: This is an observational study.
AIM I: Participants complete a survey and participate in an interview in person, over the phone, or via zoom on study.
AIM II: Participants complete an interview in person, over the phone, or via zoom on study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyAIM I: Participants complete a survey and participate in an interview in person, over the phone, or via zoom on study. AIM II: Participants complete an interview in person, over the phone, or via zoom on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sub-Saharan African immigrant men who were diagnosed with prostate cancer.
Key inclusion criteria (8 listed)
- PHASE I:
- PHASE II:
Key exclusion criteria (9 listed)
- PHASE I:
- PHASE II:
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Qualitative Interview - identification of themes and constructs
Time frame: Baseline
Data will be collected during an in-depth interview and will be analyzed with an inductive, open coding approach, first identifying themes, then constructs that emerge from the data will be categorized and mapped, noting new concepts and constructs. Theme convergence and divergence will be assessed. The interview guide focuses on participants' experiences and health-seeking behaviors regarding prostate cancer prevention, detection, decision-making, treatment, care, and survivorship.
Immigrant social determinants of health factors that impact Sub-Saharan African Immigrant (SSAI) carcinoma of the prostate (CaP) survivors
Time frame: Baseline
From the data generated in Outcome 1 interviews, an interpretive framework or theoretical model for SSAI men will be developed to evaluate and identify factors that contribute to or exacerbate disparities in prostate cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Gladys B. Asiedu, Ph.D. principal investigator
Mayo Clinic in Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Mayo Clinic at 3 sites 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 8 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Qualitative Interview - identification of themes and constructs (time frame: Baseline). 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 7 Oct 2026.