38 Participants Needed

In-Home Therapy for Prostate Cancer

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Mayo Clinic
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether receiving prostate cancer treatment at home is as safe and satisfying as receiving it in a clinic. It specifically targets Black men whose prostate cancer has spread or returned after treatment. The goal is to determine if home treatment can ease life by reducing stress and increasing comfort while maintaining effectiveness. Men currently receiving or planning to start certain prostate cancer treatments, such as Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW), and who can receive care from a home health nurse, might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you must be on or plan to start one of the eligible cancer treatment regimens, and you should continue your current treatment for at least 18 to 24 weeks, depending on the regimen.

What prior data suggests that this method is safe for in-home cancer therapy?

Research has shown that receiving cancer treatment at home is safe and well-tolerated. Early results from studies on Cancer Connected Access and Remote Expertise (CCBW) have not identified any safety issues. More than 140 chemotherapy treatments have been administered at home without problems. These findings suggest that home cancer treatment can be as safe as treatment in a clinic.12345

Why are researchers excited about this trial?

Unlike the standard of care for prostate cancer, which typically involves treatments like surgery, radiation, or hormone therapy administered in a clinical setting, the Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) approach offers a unique in-home therapy option. This treatment is distinctive because it combines initial clinic-based care with subsequent at-home treatment, allowing patients to continue their therapy in the comfort of their homes. This method not only maintains the effectiveness of standard care but also enhances convenience and accessibility, potentially improving patient compliance and quality of life. Researchers are excited about this approach as it could revolutionize how cancer care is delivered, particularly for those who face challenges accessing traditional healthcare facilities.

What evidence suggests that in-home cancer therapy using CARE Beyond Walls is effective for prostate cancer?

Research has shown that receiving cancer care at home, such as through the Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program, is safe and feasible. In this trial, participants will first receive standard care in the clinic for 6-12 weeks, then transition to home treatment with CCBW for 12-24 weeks, provided there is no disease progression or unacceptable toxicity. Studies have found that nearly 75% of patients prefer home treatment over clinic visits, indicating greater satisfaction with home care. The Mayo Clinic found that home-based care can reduce stress and financial costs. These findings support the idea that home cancer therapy might enhance overall patient well-being and improve adherence to treatment plans.13678

Who Is on the Research Team?

RS

Roxana S. Dronca, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for Black men with prostate cancer that's either locally advanced, has returned after treatment (biochemically recurrent), or has spread to other parts of the body (metastatic). It aims to see if receiving therapy at home offers benefits over in-clinic care.

Inclusion Criteria

I am receiving at least one treatment at home by a nurse.
I am 18 years old or older.
Residing within the area serviced by supplier
See 7 more

Exclusion Criteria

Receiving any other investigational agent for the primary neoplasm
I do not have any severe illnesses that would prevent me from joining the study.
I do not have any severe illnesses or conditions that are not under control.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-clinic Treatment

Participants receive standard of care treatment in the clinic

6-12 weeks
Regular in-person visits

At-home Treatment

Participants receive treatment in the home with CCBW in the absence of disease progression or unacceptable toxicity

12-24 weeks
Remote monitoring and support

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW)
Trial Overview The study compares the safety, side effects, patient preference, and satisfaction between receiving cancer therapy at home using CARE Beyond Walls versus traditional in-clinic treatment. The impact on psychological and financial stress will also be assessed.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (in clinic treatment, in home treatment)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Cancer Care Beyond Walls: Home vs. In-Clinic Therapy TrialThis pragmatic randomized controlled trial evaluates feasibility and impact of home-based versus in-clinic cancer directed therapy on patient preference, ...
Roxana Dronca, MD, Jeremy Jones, MD, Chanice Howard, MPHCollect data on patient understanding and acceptability of cancer care at home. โ€ข Develop strategies for overcoming cancer care delivery disparities and ...
Nearly Three-Quarters of Patients Prefer Home-Based ...Home-based cancer care is safe, feasible, and preferred by most patients, according to early findings from a Mayo Clinic study presented at ...
RePORT โŸฉ RePORTERWe're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.
Is home-based treatment the future of cancer care?"Cancer CARE Beyond Walls provides patients with cutting-edge, infusion-based technology and patient-centered care in the comfort of their own ...
Study Details | Evaluating In Home Cancer Therapy Versus In ...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, ...
At-Home Cancer Directed Therapy versus in Clinic for the ...This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread.
A pilot single-arm, pragmatic trial in progress of in-home ...This trial evaluates the safety, acceptability, and impact of home-based subcutaneous (SC) nivolumab (Nivo) administration compared to in-clinic treatment.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity