Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT07073794
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home.
II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery.
SAFETY OBJECTIVES:
I. To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery.
II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment).
III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment.
SECONDARY OBJECTIVE:
I. To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes.
EXPLORATORY OBJECTIVES:
I. To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery.
II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home.
OUTLINE:
Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.
I. To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home.
II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery.
SAFETY OBJECTIVES:
I. To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery.
II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment).
III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment.
SECONDARY OBJECTIVE:
I. To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes.
EXPLORATORY OBJECTIVES:
I. To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery.
II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home.
OUTLINE:
Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: