Health Trials

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

ConditionsAdvanced Anal CarcinomaAdvanced Biliary Tract CarcinomaAdvanced Bladder CarcinomaAdvanced Breast CarcinomaAdvanced Carcinoid TumorAdvanced Cervical CarcinomaAdvanced Colorectal CarcinomaAdvanced Gastric CarcinomaAdvanced GlioblastomaAdvanced Head and Neck CarcinomaAdvanced HER2 Positive Breast CarcinomaAdvanced Lung CarcinomaAdvanced Lung Small Cell CarcinomaAdvanced Malignant Germ Cell TumorAdvanced Malignant Solid NeoplasmAdvanced Neuroendocrine CarcinomaAdvanced Ovarian CarcinomaAdvanced Pancreatic CarcinomaAdvanced Prostate Small Cell Neuroendocrine CarcinomaAdvanced Prostate CarcinomaHematopoietic and Lymphoid System NeoplasmMultiple MyelomaMyelodysplastic SyndromeAdvanced Basal Cell CarcinomaAdvanced CholangiocarcinomaAdvanced Endometrial CarcinomaAdvanced Esophageal CarcinomaAdvanced Fallopian Tube CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Liver CarcinomaAdvanced LymphomaAdvanced Malignant Testicular NeoplasmAdvanced MelanomaAdvanced Merkel Cell CarcinomaAdvanced Penile CarcinomaAdvanced Primary Malignant Central Nervous System NeoplasmAdvanced Renal Cell CarcinomaAdvanced SarcomaAdvanced Skin Squamous Cell CarcinomaAdvanced Urethral CarcinomaAdvanced Vaginal CarcinomaAdvanced Vulvar CarcinomaAdvanced Appendix CarcinomaAdvanced Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About 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.

Eligibility criteria

Qualifiers

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.

Anal cancer

Appendiceal carcinoma

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Clinical Encounter
  • Home Health Encounter
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov