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

Launched by MAYO CLINIC · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether cancer treatment can be more effective and convenient when given at home instead of in a clinic. The study focuses on patients with advanced cancer that has spread to other parts of the body, such as advanced breast, lung, or prostate cancer. By allowing treatments at home, the trial aims to reduce the stress and costs associated with traditional hospital visits, making it easier for patients and their families to manage their care.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed diagnosis of specific types of cancer and currently receiving certain chemotherapy regimens. They need to have reliable internet access for virtual support and must be able to follow the study guidelines. If you join the trial, you can expect to receive your cancer treatment at home with support from healthcare professionals, aiming to improve your overall well-being during this challenging time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible chemotherapy treatment regimens:
• • Cisplatin/gemcitabine for bladder, lung, or biliary cancer
• • Gemcitabine for pancreatic, biliary or ovarian cancer
• • Cisplatin/etoposide for small cell lung cancer, germ cell carcinoma, small cell prostate cancer, and neuroendocrine/carcinoid cancer
• • Cisplatin for lung, bladder, head and neck, or cervical cancer
• • Avastin for glioblastoma, colorectal, and cervical cancer
• • Avastin, avastin + temozolomide, avastin + lomustine, or avastin + afinitor for glioblastoma
• • Cisplatin/fluorouracil (5-FU) for anal cancer
• • 5-FU/leucovorin +/- Avastin for colorectal, pancreas or gastric cancer
• • FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal, pancreas cancer
• • Paclitaxel for breast cancer, bladder cancer
• • Trastuzumab with or without pertuzumab maintenance (subcutaneously \[SQ\] or intravenously \[IV\]) for HER2 positive breast cancer in the adjuvant or metastatic setting
• • Trastuzumab + paclitaxel for Her-2 positive breast cancer
• • Leuprolide for prostate cancer and breast cancer
• • Degarelix for prostate cancer
• • Goserelin acetate for breast cancer
• • Fulvestrant for breast cancer
• • Bortezomib for multiple myeloma
• • Carfilzomib for multiple myeloma
• • Decitabine for myelodysplastic syndrome
• * Only patients receiving decitabine for myelodysplastic syndrome (MDS) are eligible for these supportive medications:
• • Darbepoetin-alfa
• • Epoetin
• • Filgrastim
• * Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible supportive care drugs for treatment of bone metastases:
• • Zoledronic acid
• • Denosumab
• • Patient has had adequate tolerability of their clinical standard of care chemotherapy 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
• • 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 judgment
• • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• • Ability to complete questionnaire(s)
• • 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 chemotherapy treatment 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
• • Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed coronavirus disease 2019 \[COVID-19\] infection)
• • Anticipation of the need for major surgery during the course of study treatment. Note: concomitant radiation therapy during the study period is allowed