At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

Recruiting now · Phase 2

Conditions studied: Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma, Advanced Bladder Carcinoma, Advanced Breast Carcinoma, Advanced Carcinoid Tumor, Advanced Cervical Carcinoma, Advanced Colorectal Carcinoma, Advanced Gastric Carcinoma, Advanced Glioblastoma, Advanced Head and Neck Carcinoma, Advanced HER2 Positive Breast Carcinoma, Advanced Lung Carcinoma, Advanced Lung Small Cell Carcinoma, Advanced Malignant Germ Cell Tumor, Advanced Malignant Solid Neoplasm, Advanced Neuroendocrine Carcinoma, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma, Advanced Prostate Small Cell Neuroendocrine Carcinoma, Advanced Prostate Carcinoma, Hematopoietic and Lymphoid System Neoplasm, Multiple Myeloma, Myelodysplastic Syndrome, Advanced Basal Cell Carcinoma, Advanced Cholangiocarcinoma, Advanced Endometrial Carcinoma, Advanced Esophageal Carcinoma, Advanced Fallopian Tube Carcinoma, Advanced Hepatocellular Carcinoma, Advanced Liver Carcinoma, Advanced Lymphoma, Advanced Malignant Testicular Neoplasm, Advanced Melanoma, Advanced Merkel Cell Carcinoma, Advanced Penile Carcinoma, Advanced Primary Malignant Central Nervous System Neoplasm, Advanced Renal Cell Carcinoma, Advanced Sarcoma, Advanced Skin Squamous Cell Carcinoma, Advanced Urethral Carcinoma, Advanced Vaginal Carcinoma, Advanced Vulvar Carcinoma, Advanced Appendix Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05969860

Run by

Mayo Clinic

People needed

220

Starts

2023-08-23

Expected to finish

2027-01-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Altru Cancer Center — Grand Forks, North Dakota, United States (enrolling)

Full record on ClinicalTrials.gov

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