Actively Recruiting
Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic
Led by Mayo Clinic · Updated on 2026-04-20
220
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of delivering cancer-directed therapy at home versus in a clinic for patients with advanced cancer that has spread beyond its original site. This trial aims to reduce the physical, emotional, social, and financial burdens of cancer treatment, which often requires long visits to infusion centers or specialty hospitals. By exploring virtual care models, the study seeks to improve quality of life and treatment adherence, especially for marginalized patients and communities. Participants first receive at least one cycle of their standard cancer treatment in the clinic. They are then randomly assigned to one of two groups: one group continues treatment at home for about 24 weeks with support from a home health nurse and a remote Command Center, including health monitoring devices and video visits. The other group receives about 8 weeks of treatment in the clinic before switching to home treatment for an additional 16 weeks under the same home health program. During the study, patients undergo routine lab tests, drug infusions, and health monitoring either at home or in the clinic. Researchers collect patient feedback on access to care, treatment preferences, comfort levels, quality of life, symptoms, and safety through questionnaires and monitoring tools. They also track adverse events, emergency visits, hospitalizations, and overall survival. After completing treatment, participants are followed for one year to assess longer-term outcomes.
CONDITIONS
Brief Title
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients with histologically confirmed malignancy or imaging diagnosis of hepatocellular carcinoma
- Receiving a standard-of-care treatment regimen approved or recommended for their cancer type
- Patients with eligible cancer types including but not limited to anal, breast, lung, lymphoma, melanoma, prostate, ovarian, and others as listed
- Acceptable regimens include various FDA-approved chemotherapy, immunotherapy, and combination treatments
- Adequate tolerability to current cancer treatment with no prior drug-related infusion reactions
- Plan to continue current treatment for at least 24 weeks following randomization
- Residing in an area serviced by the home health supplier and paramedic network
- Residence with WiFi or suitable wireless connection for remote monitoring
- Age 18 years or older at registration
- Signed informed consent
- Willing and able to comply with study protocol
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Ability to complete questionnaires independently or with assistance
- Confirmation of treatment tolerability and no infusion reactions prior to registration
You will not qualify if you...
- Receiving any other investigational treatment for the primary cancer
- Need for 24/7 assistance with daily living activities
- Currently hospitalized as an inpatient (excluding advanced care at home program)
- Severe co-morbid illnesses or diseases that may interfere with safety assessment
- Uncontrolled illness including active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, recent myocardial infarction (within 6 months), wound healing disorder, or psychiatric/social issues limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm eligibility and treatment tolerability
Duration - Up to 24 weeks
Participants receive their standard-of-care cancer treatment either at home or in the clinic depending on randomization. Arm A participants receive treatment at home for approximately 24 weeks, including drug administrations, injections/infusions, routine clinical laboratory tests, and remote monitoring. Arm B participants receive treatment in the clinic for approximately 8 weeks, then continue treatment at home for about 16 weeks in a similar manner.
Regular visits for treatment administration and monitoring either at home or in clinic, with video visits and health monitoring devices provided for home treatment
Duration - 1 year
After completing the treatment phase, participants are followed for up to 1 year to assess overall survival and other long-term outcomes.
Periodic follow-up visits or contacts to monitor health status and survival
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
2
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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