At-Home vs. In-Clinic Cancer Treatment for Advanced Cancers
This study is looking at whether receiving cancer treatment at home is as good as, or better than, getting it in a clinic for people with advanced cancer. Advanced cancer means the cancer may have spread. Most cancer treatments are given in a clinic, which can be hard on patients and families. This study wants to see if at-home care, using 'Home Health Encounter' (treatment at home) compared to 'Clinical Encounter' (treatment in clinic), can improve how patients feel about their care. We're hoping to enroll about 220 people aged 18 or older with various advanced cancers, including breast, bladder, and anal carcinoma, who are already receiving standard cancer treatment. The main goal is to measure how patients rate their access to and experience with cancer care after 8 weeks.
- Study design
- This is an interventional study comparing at-home treatment to in-clinic treatment. It plans to enroll 220 participants.
- What's involved
- Participants will receive either at-home treatment or in-clinic treatment. They will also complete quality-of-life assessments and questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 8 weeks, and some patient experience questions are assessed after 24 weeks of treatment.
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NCT05969860
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~220 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Clinical EncounterHome Health EncounterQuality-of-Life AssessmentQuestionnaire Administration
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean patient-reported rating of Cancer Connected Access and Remote Expertise
Measured over At 8 weeks
Conditions
Where it's being run
2 sites across 2 statesFlorida1
North Dakota1
Study leadership
- Roxana S. Dronca, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.
Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.
Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:
Eligible disease cancer types:
Anal cancer
Appendiceal carcinoma
Basal cell carcinoma
Bladder cancer
Biliary cancer
Breast cancer
Central Nervous System malignancy including glioblastoma
Cervical cancer
Cholangiocarcinoma
Colorectal carcinoma
Endometrial cancer
Fallopian tube cancer
Gastroesophageal cancer \[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\]
Germ cell carcinoma
Head and Neck cancer
Hepatocellular Carcinoma
Liver
Lung
Lymphoma
Melanoma
Merkel Cell
Multiple Myeloma
Myelodysplastic syndrome
Myeloid Disorders
Neuroendocrine carcinoma
Ovarian cancer
Pancreatic adenocarcinoma
Penile carcinoma
Peritoneal carcinoma
Prostate cancer
Renal cell cancer
Sarcoma
Squamous cell Carcinoma of the Skin
Testicular cancer
Urethral carcinoma
Vaginal carcinoma
Vulvar carcinoma
Eligible Regimens
Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab
5FU +/- leucovorin +/- bevacizumab +/- nivolumab
Atezolizumab +/- bevacizumab
Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib
Avelumab
Avelumab + axitinib
Bevacizumab
Bevacizumab + capecitabine
Bevacizumab + irinotecan (+/- capecitabine)
Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib
Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus
Bevacizumab + trifluridine/tipiracil
Bortezomib
Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
Bortezomib + venetoclax
Carfilzomib
Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor
Carfilzomib + venetoclax
Cemiplimab
Cisplatin
Cisplatin/5-FU
Cisplatin/etoposide
Cisplatin + durvalumab
Cisplatin + gemcitabine
Cisplatin + gemcitabine + durvalumab
Daratumumab (+ oral \[PO\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
Degarelix
Durvalumab
Durvalumab + tremelimumab
Eribulin
FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)
Fam-trastuzumab deruxtecan
Fulvestrant
Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib
Gemcitabine
Gemcitabine + durvalumab
Gemcitabine + paclitaxel protein-bound
Goserelin acetate
Irinotecan
Irinotecan + capecitabine
Lanreotide
Leuprolide
Nivolumab
Nivolumab + cabozantinib
Nivolumab-relatlimab
Octreotide
Paclitaxel
Pembrolizumab
Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)
Pemetrexed
Pertuzumab
Pemetrexed + pembrolizumab
Rituximab
Trastuzumab + paclitaxel
Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)
Decitabine
These regimens can be used only if patients are receiving one of the regimens above:
Darbepoetin-alfa
Epoetin
Filgrastim
Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:
Zoledronic acid
Denosumab
Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent
Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.
Residing within the area serviced by supplier and paramedic network
Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution
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 judgement
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
Ability to complete questionnaire(s) by themselves or with assistance
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 cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration
Exclusion
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 endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \[IM\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. 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
What this trial measures
- Mean patient-reported rating of Cancer Connected Access and Remote ExpertiseAt 8 weeks
This hypothesis test will use patient ratings from a single 0-10 item from the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey assessing "your overall cancer care experience". Will be compared between arms using a two-sample t-test.