NCT05969860 · Mayo Clinic
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
What this study is about
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).
View original scientific description
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.
Interventions
PROCEDURE
Clinical Encounter
Receive treatment in clinic
OTHER
Home Health Encounter
Receive at-home treatment
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Mean patient-reported rating of Cancer Connected Access and Remote Expertise
Time frame: At 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Merkel Cell
- Multiple Myeloma
- Myelodysplastic syndrome
- Myeloid Disorders
- Neuroendocrine carcinoma
- Ovarian cancer
- Pancreatic adenocarcinoma
- Penile carcinoma
- Peritoneal carcinoma
- Prostate cancer
- Renal cell cancer
- 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 + 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 + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
- Bortezomib + venetoclax
- Carfilzomib
- Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor
- Carfilzomib + venetoclax
- 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)
- Durvalumab + tremelimumab
- 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 + capecitabine
- Nivolumab + cabozantinib
- Nivolumab-relatlimab
- Pembrolizumab
- Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)
- Pemetrexed + pembrolizumab
- Trastuzumab + paclitaxel
- Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)
- These regimens can be used only if patients are receiving one of the regimens above:
- Darbepoetin-alfa
- 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
- 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 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 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
Where
- Jacksonville, Florida
- Grand Forks, North Dakota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations