Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic CANCER CARE BEYOND WALLS

What's the purpose of this trial?

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 from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible chemotherapy treatment regimens:

* Cisplatin/gemcitabine for bladder, lung, or biliary cancer
* Gemcitabine for pancreatic, biliary or ovarian cancer
* Cisplatin/etoposide for small cell lung cancer, germ cell carcinoma, small cell prostate cancer, and neuroendocrine/carcinoid cancer
* Cisplatin for lung, bladder, head and neck, or cervical cancer
* Avastin for glioblastoma, colorectal, and cervical cancer
* Cisplatin/fluorouracil (5-FU) for anal cancer
* 5-FU/leucovorin +/- Avastin for colorectal, pancreas or gastric cancer
* FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal, pancreas cancer
* Paclitaxel for breast cancer, bladder cancer
* Trastuzumab with or without pertuzumab maintenance (subcutaneously \[SQ\] or intravenously \[IV\]) for HER2 positive breast cancer in the adjuvant or metastatic setting
* Trastuzumab + paclitaxel for Her-2 positive breast cancer
* Leuprolide for prostate cancer and breast cancer
* Degarelix for prostate cancer
* Goserelin acetate for breast cancer
* Fulvestrant for breast cancer
* Bortezomib for multiple myeloma
* Carfilzomib for multiple myeloma
* Decitabine for myelodysplastic syndrome

* Only patients receiving decitabine for myelodysplastic syndrome (MDS) are eligible for these supportive medications:

* Darbepoetin-alfa
* Epoetin
* Filgrastim
* Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible supportive care drugs for treatment of bone metastases:

* Zoledronic acid
* Denosumab
* Patient has had adequate tolerability of their clinical standard of care chemotherapy treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent
* Patients have no documented reason to suspect they will not continue the treatment regimen they are currently prescribed for at least 24 weeks of treatment
* Residing within 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network
* Residence either has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center
* Age \>= 18 years at time of registration
* Signed informed consent form by patient
* Willing and able to comply with the study protocol in the investigator's judgment
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
* Ability to complete questionnaire(s)
* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care chemotherapy treatment and no drug-related infusion reactions since pre-registration and prior to registration

Exclusion Criteria:

* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with fulvestrant intramuscular (IM); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc) if used in combination with any of the drugs
* Requiring 24/7 assistance with activities of daily living (ADLs)
* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to:

* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Myocardial infarction =\< 6 months
* Wound healing disorder
* Or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed coronavirus disease 2019 \[COVID-19\] infection)
* Anticipation of the need for major surgery during the course of study treatment. Note: concomitant radiation therapy during the study period is allowed

Additional Trial Information

Phase 2

Enrollment: 200 patients (estimated)

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Trial Locations

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Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting
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