Clinical trial NCT06470750: Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) with Advanced Prostate Cancer (CaP)
Official title: Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) with Advanced Prostate Cancer (CaP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Prostate Adenocarcinoma
Metastatic Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC V8
Stage IVB Prostate Cancer AJCC V8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer, as well as individuals identifying as an African American/Black man with prostate adenocarcinoma requiring prostate cancer therapy and individuals identifying as an African American/Black man with prostate adenocarcinoma requiring active standard hormone-based therapies, antibone resorptive agents, oral anticancer treatments, or intravenous chemotherapy and receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of the Advanced Care at Home Program

Brief summary: This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with advanced prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate a highly innovative project evaluating the feasibility of patient-centered home care PCHC as a new model of cancer care to reduce disparities and improve health related QoL (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP). (Phase I) II. Establish patient-centeredness by exploring patients' choice relative to the place of CaP treatment for certain aspects of therapy as well as end-of-life care.

III. Establish the acceptance and impact of PCHC on PROs and HRQoL in BM with advanced CaP.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

GROUP 1: Participants take part in a focus group or complete questionnaires and may take part in an interview on study.

GROUP 2: Participants complete questionnaires throughout the study.

Eligibility criteria: Inclusion Criteria:

* GROUP 1 FOCUS GROUPS:

  * Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer

GROUP 1 SURVEYS:

* Are 18 years of age or older
* Have histologic evidence of prostate adenocarcinoma
* Are requiring prostate cancer therapy
* Have an understanding of the protocol and its requirements
* Are willing to fill in a questionnaire and participate in a focused interview
* Are able and willing to sign an informed consent

GROUP 1 INTERVIEWS:

* Enrollment in the survey phase of the protocol

GROUP 2:

* Are 18 years of age or older
* Have histologic evidence of prostate adenocarcinoma
* Are requiring active standard hormone-based therapies (degarelix or leuprolide), antibone resorptive agents (zoledronic acid or denosumab), oral anticancer treatments (abiraterone or second-generation androgen receptor blockers) or intravenous chemotherapy (docetaxel)
* Are receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of advanced care at home program (ACH)
* Have an understanding of the protocol and its requirements
* Are able and willing to sign an informed consent

Exclusion Criteria:

* GROUP 1 FOCUS GROUPS:

  * Individuals who do not identify as Black or male or who have had no extensive interaction with the healthcare system

GROUP 1 SURVEYS:

* Do not identify as Black men
* Have not been diagnosed with advanced/metastatic CaP
* Are not requiring active standard anti-cancer therapy

GROUP 1 INTERVIEWS:

* Not enrolled in the survey phase of the protocol

GROUP 2:

* Do not identify as Black men
* Have not been diagnosed with advanced/metastatic CaP
* Are not requiring active standard anti-cancer therapy

Primary outcomes:
measure: Feasibility of Patient-centered Home Care (PCHC)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Time to emergency room visit
timeFrame: Up to 6 months
measure: Time to hospital visit
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Roxana S. Dronca, MD
role: PRINCIPAL_INVESTIGATOR
References: