Recruiting
Phase 2

At-Home Therapy

Sponsor:

Mayo Clinic

Code:

NCT05969860

Conditions

Advanced Anal Carcinoma

Advanced Biliary Tract Carcinoma

Advanced Bladder Carcinoma

Advanced Breast Carcinoma

Advanced Carcinoid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Encounter

Home Health Encounter

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief summary:

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.

Conditions

Advanced Anal Carcinoma

Advanced Biliary Tract Carcinoma

Advanced Bladder Carcinoma

Advanced Breast Carcinoma

Advanced Carcinoid Tumor

Study ID

NCT05969860

Start date

Aug 23, 2023

Status verified date

Apr, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • 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 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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (at-home treatment)

Patients continue receiving their SOC treatment regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

experimental: Arm B (clinic & at-home treatment)

Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

Clinical Encounter

Receive treatment in clinic

Home Health Encounter

Receive at-home treatment

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Mean patient-reported rating of Cancer Connected Access and Remote Expertise [ Time Frame: At 8 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Roxana S. Dronca, MD

Altru Cancer Center

Recruiting

Grand Forks, North Dakota, United States, 58201

Contacts

Alexis Tatum

701-780-5400atatum@altru.org

Principal Investigator:

Grant Seeger, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-20.