Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Mean patient-reported rating of Cancer Connected Access and Remote Expertise
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:
- •Eligible disease cancer types:
- •Anal cancer
- •Appendiceal carcinoma
- •Basal cell carcinoma
- •Bladder cancer
- •Biliary cancer
- •Breast cancer
- •Central Nervous System malignancy including glioblastoma
- •Cervical cancer
- •Cholangiocarcinoma
- •Colorectal carcinoma
- •Endometrial cancer
- •Fallopian tube cancer
- •Gastroesophageal cancer [including gastric, esophageal, and gastroesophageal junction (GEJ) cancers]
- •Germ cell carcinoma
- •Head and Neck cancer
- •Hepatocellular Carcinoma
- •Merkel Cell
- •Multiple Myeloma
- •Myelodysplastic syndrome
- •Myeloid Disorders
- •Neuroendocrine carcinoma
- •Ovarian cancer
- •Pancreatic adenocarcinoma
- •Penile carcinoma
- •Peritoneal carcinoma
- •Prostate cancer
- •Renal cell cancer
- •Squamous cell Carcinoma of the Skin
- •Testicular cancer
- •Urethral carcinoma
- •Vaginal carcinoma
- •Vulvar carcinoma
- •Eligible Regimens
- •Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab
- •5FU +/- leucovorin +/- bevacizumab +/- nivolumab
- •Atezolizumab +/- bevacizumab
- •Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib
- •Avelumab + axitinib
- •Bevacizumab
- •Bevacizumab + capecitabine
- •Bevacizumab + irinotecan (+/- capecitabine)
- •Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib
- •Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus
- •Bevacizumab + trifluridine/tipiracil
- •Bortezomib
- •Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
- 另有 59 项未显示
排除标准
- •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
研究组 & 干预措施
Arm B (clinic & at-home treatment)
Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm A (at-home treatment)
Patients continue receiving their SOC treatment 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.
干预措施: Home Health Encounter (Other)
Arm A (at-home treatment)
Patients continue receiving their SOC treatment 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.
干预措施: Quality-of-Life Assessment (Other)
Arm A (at-home treatment)
Patients continue receiving their SOC treatment 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.
干预措施: Questionnaire Administration (Other)
Arm B (clinic & at-home treatment)
Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Clinical Encounter (Procedure)
Arm B (clinic & at-home treatment)
Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Home Health Encounter (Other)
Arm B (clinic & at-home treatment)
Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Mean patient-reported rating of Cancer Connected Access and Remote Expertise
时间窗: At 8 weeks
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.
次要结局
- Patient-reported function(At 8 weeks)
- Overall survival(The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention)
- Patient-reported worthwhileness(At 24 weeks)
- Incidence of adverse events(Up to 24 weeks)
- Patient-preferred treatment location(At 24 weeks)
- Patient-reported side effect impact(At 8 weeks)
- Emergency room visits and hospitalizations(At 8 weeks)
- Patient level of comfort with receiving infusions at home(At 24 weeks)
- Patient-reported symptoms(At 8 weeks)