Trial Title:
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients with Advanced Cancer
NCT ID:
NCT05969860
Condition:
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
Conditions: Official terms:
Carcinoma
Neoplasms
Multiple Myeloma
Glioblastoma
Breast Neoplasms
Colorectal Neoplasms
Carcinoid Tumor
Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Clinical Encounter
Description:
Receive treatment in clinic
Arm group label:
Arm B (clinic & at-home treatment)
Other name:
Patient Encounter
Intervention type:
Other
Intervention name:
Home Health Encounter
Description:
Receive at-home treatment
Arm group label:
Arm A (at-home treatment)
Arm group label:
Arm B (clinic & at-home treatment)
Other name:
HH
Other name:
Home
Other name:
Home Care Visit
Other name:
Home Health
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm A (at-home treatment)
Arm group label:
Arm B (clinic & at-home treatment)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm A (at-home treatment)
Arm group label:
Arm B (clinic & at-home treatment)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare mean patient-reported rating of Cancer Connected Access and Remote
Expertise (CARE) using a modified question from the Consumer Assessment of Healthcare
Providers and Systems (CAHPS) Cancer Care Survey after 8 weeks between patients
randomized to receive care at home and care in the clinic.
SECONDARY OBJECTIVES:
I. To evaluate patient preference for location of cancer treatment administration, at the
infusion center or in the home.
II. To evaluate level of comfort with receiving infusions at home based on the following
measures after 24 weeks of treatment:
IIa. The proportion of patients who indicate a preference for home infusion or no
preference versus outpatient infusion unit administration of cancer treatment as assessed
via the Patient Preference Questionnaire; IIb. The proportion of patients who indicate
comfort (quite a bit or very much) with receiving infusions at home as assessed by the
Patient Preference Questionnaire.
III. To describe other patient experience questions within the Patient Preference
Questionnaire after 24 weeks of treatment.
IV. To describe whether patients felt that infusions at home was worthwhile, would do it
again, and recommend it to others after 24 weeks of treatment using the Was It Worth It
questionnaire.
V. To test whether home-based virtual delivery of cancer directed therapy is superior to
standard administration (in clinic) in patient-reported function and global
health/quality of life as measured by the European Organization for Research and
Treatment of Cancer Quality of Life Questionnaire Core Function 17-Item (EORTC QLQ-F17)
after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.
VI. To test whether home-based virtual delivery of cancer directed therapy is superior to
standard administration (in clinic) in patient-reported symptoms as measured by the
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.
VII. To assess the safety of cancer directed therapy when administered at home by a home
health provider with remote patient monitoring and Command Center support, based on the
incidence, nature, and severity of the following:
VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute
Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
VIII. To test whether home-based virtual delivery of cancer directed therapy is superior
to standard in clinic administration in the proportion of patients with an emergency room
visit or hospitalization at the end of 6 months of study treatment.
IX. Overall survival.
EXPLORATORY OBJECTIVES:
I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To
evaluate administration of treatment based on clinical practice data.
OUTLINE:
Patients receive at least 1 cycle of their standard of care (SOC) chemotherapy regimen in
the clinic in the absence of disease progression or unacceptable toxicity. Patients are
then randomized to 1 of 2 arms.
ARM A: Patients continue receiving their SOC chemotherapy 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 Home Health Nurse Provider (HHNP), overseen by Mayo Clinic's
home health program Cancer CARE Beyond Walls (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.
ARM B: Patients continue receiving their SOC chemotherapy regimen in the clinic for
approximately 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an
approximate additional 16 weeks in the absence of disease progression or unacceptable
toxicity.
After completion of study intervention, patients are followed for 1 year.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Roxana S. Dronca, MD
Start date:
August 23, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05969860
https://www.mayo.edu/research/clinical-trials
