Clinical trial NCT05969860: At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Official title: Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: Mean patient-reported rating of Cancer Connected Access and Remote Expertise
timeFrame: At 8 weeks
Secondary outcomes:
measure: Patient-preferred treatment location
timeFrame: At 24 weeks
measure: Patient level of comfort with receiving infusions at home
timeFrame: At 24 weeks
measure: Patient-reported worthwhileness
timeFrame: At 24 weeks
measure: Patient-reported function
timeFrame: At 8 weeks
measure: Patient-reported symptoms
timeFrame: At 8 weeks
measure: Patient-reported side effect impact
timeFrame: At 8 weeks
measure: Incidence of adverse events
timeFrame: Up to 24 weeks
measure: Emergency room visits and hospitalizations
timeFrame: At 8 weeks
measure: Overall survival
timeFrame: The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Grand Forks
country: United States
facility: Altru Cancer Center
state: North Dakota
Study officials:
affiliation: Mayo Clinic
name: Roxana S. Dronca, MD
role: PRINCIPAL_INVESTIGATOR
References: