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

Study Overview
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Brief Summary
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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
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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 (or at end of study): 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 (or at end of study). 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 (or at end of study) 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 the first 2 cycles 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.

Official Title
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Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic

Conditions
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Advanced Malignant Solid Neoplasm, 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 Neuroendocrine Carcinoma, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma, Prostate Small Cell Neuroendocrine Carcinoma, Advanced Prostate Carcinoma

Intervention / Treatment
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* Procedure: Clinical Encounter
* Other: Home Health Encounter
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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, biliary, or breast cancer Gemcitabine for pancreatic 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, cervical, and breast cancer, and glioblastoma Avastin for glioblastoma, breast, colorectal, and cervical cancer Cisplatin/fluorouracil (5-FU) +/- Avastin for anal cancer 5-FU/leucovorin +/- Avastin for colorectal or gastric cancer FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal cancer Paclitaxel for breast or bladder cancer Trastuzumab maintenance for Her-2 positive breast cancer Trastuzumab + paclitaxel for Her-2 positive breast cancer Leuprolide for prostate and breast cancer (monthly or every three month regimen only) Goserelin acetate for breast cancer 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 have no documented reason to suspect they won't continue the treatment regimen they are currently prescribed for at least 24 weeks of treatment Residing within 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network Residence has wireless fidelity (Wi-Fi) 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 or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimens (except hormone therapy for breast or prostate cancer) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (at-home treatment)<br>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 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. | Other: Home Health Encounter<br>* Receive at-home treatment<br>* Other names: Home Health;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm B (clinic & at-home treatment)<br>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. | Procedure: Clinical Encounter<br>* Receive treatment in clinic<br>* Other names: Patient Encounter;Other: Home Health Encounter<br>* Receive at-home treatment<br>* Other names: Home Health;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean patient-reported rating of Cancer Connected Access and Remote Expertise | This hypothesis test will use patient ratings from a single 0-10 item from the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey assessing your overall cancer care experience. Will be compared between arms using a two-sample t-test. | At 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-preferred treatment location | The proportion of patients who preferred care at home or expressed no preference will be computed and compared to 50% using a one-group test of proportions. Additional Likert patient feedback questions and Was It Worth It questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests. | At 24 weeks | 
| Patient level of comfort with receiving infusions at home | Patient responses to comfort level with receiving infusions at home will be described using frequencies and relative frequencies. The proportion of patients who express comfort (quite a bit or very much) will also be tabulated and a proportion greater than 70% will signify acceptance. Additional Likert patient feedback questions and Was It Worth It questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests. | At 24 weeks | 
| Patient-reported worthwhileness | Measured by the Was it Worth It questionnaire. The Was It Worth It questionnaire asks patients whether they thought that receiving chemo/infusions at home was worthwhile, whether they would do it again, and whether they would recommend it to others. | At 24 weeks | 
| Patient-reported function | Measured by the European Organization for Research and Treatment of Cancer. Mean and standard deviation of each scale will be computed by arm. Means and standard deviations of each scale will also be computed at all other assessment time points. Mean changes from baseline in each scale at 8 weeks (and other assessment time points) will be compared between arms using a linear combination of parameters from a general linear mixed model. Each model will include all available data from all time points. Fixed effects will include arm, time point, and arm-by-time point interaction. Repeated observations by patient will be modeled using compound symmetric correlation structure over time. Such values as the mean change from baseline at 8 weeks by arm, and difference in mean change from baseline at 8 weeks between arms will be estimated with confidence intervals based on the mixed model. Comparisons at other time points will also be carried out and graphically displayed using mean plots. | At 8 weeks | 
| Patient-reported symptoms | Will be measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (CTCAE) and summarized using composite grades. The baseline adjustment approach will be applied and resulting maximum baseline-adjusted grade will be reported by symptomatic adverse events (AE) as the proportion of patients with at least one grade >=1 AE during the first 8 weeks. The proportion of patients with at least one grade >= 3 AE per symptomatic AE will also be tabulated during the first 8 weeks. Comparisons between arms will employ Fisher's exact tests. Additional summaries over the 24 weeks by tables and graphics will also be generated. | At 8 weeks | 
| Patient-reported side effect impact | Will be measured by the General Physical-5 (GP5). The frequency and relative frequency of patient responses to the GP5 at 8 weeks will be computed by arm and compared between arms using a chi-squared test. The categorical analysis will also be computed at other assessment time points. Mean GP5 scores over time will also be explored using a general linear mixed model and mean plots. | At 8 weeks | 
| Incidence of adverse events | The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. The frequency and percentage of grade 3+ adverse events (by individual AEs and overall) will be reported by arm and compared between arms using a Fisher's exact test. | Up to 24 weeks | 
| Emergency room visits and hospitalizations | The proportion of patients with an emergency room visit or hospitalization will be computed per arm and compared between arms using a Fisher's exact test. In subsequent analyses, emergency room visits and hospitalizations will be explored separately. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study. | At 8 weeks | 
| Overall survival | Will be estimated using the Kaplan-Meier method and compared between arms using a log-rank test. | The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention |