Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Patient preferences regarding location of cancer treatment delivery
研究概览
简要总结
This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent
- •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) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], American Society of Hematology [ASH], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines
- •A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician
- •Female or male patients age >= 18 years at the time of consent
- •Willing and able to comply with the study protocol in the investigator's judgement
- •Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.
- •Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens
- •Eligible disease cancer types:
- •Amyloidosis
- •Basal cell carcinoma
- •Colorectal
- •Endometrial
- •Fallopian tube
- •Gastroesophageal
- •Glioblastoma
- •Head and neck
- •Hepatocellular
- •Hodgkin lymphoma
- •Mantle cell lymphoma
- •Merkle cell carcinoma
- •Multiple myeloma
- •Myelodysplastic syndrome
- •Pancreatic
- •Peritoneal
- •Renal cell carcinoma
- •Squamous cell carcinoma
- •Urothelial carcinoma
- •Eligible regimens
- •Atezolizumab +/- bevacizumab
- •Bevacizumab
- •Bortezomib
- •Cemiplimab
- •Daratumumab +/- bortezomib
- •Darbepoetin alpha
- •Degarelix
- •Denosumab (Xgeva)
- •Durvalumab
- •Fluorouracil +/- bevacizumab
- •Fulvestrant
- •Goserelin
- •Ipilimumab +/- Nivolumab
- •Lanreotide
- •Leuprolide
- •Nivolumab
- •Nivolumab + relatlimab
- •Octreotide
- •Pembrolizumab
- •Pertuzumab +/- trastuzumab
- •Trastuzumab +/- pertuzumab
- 另有 8 项未显示
排除标准
- •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
- •Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.
- •Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial
- •Individuals who require continuous (24/7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study
- •Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
研究组 & 干预措施
Health services research (CCBW in-home cancer treatment)
Patients receive in-home standard of care cancer-treatment through CCBW according to standard clinical practice for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Following 12 weeks of in-home treatment, patients choose to return to clinic setting or continue to receive in-home treatment for an additional 12 weeks.
干预措施: Questionnaire Administration (Other)
Health services research (CCBW in-home cancer treatment)
Patients receive in-home standard of care cancer-treatment through CCBW according to standard clinical practice for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Following 12 weeks of in-home treatment, patients choose to return to clinic setting or continue to receive in-home treatment for an additional 12 weeks.
干预措施: Cancer Therapeutic Procedure (Drug)
结局指标
主要结局
Patient preferences regarding location of cancer treatment delivery
时间窗: At 12 weeks
As assessed by a single item asking patients to rate their preferred location for cancer treatment delivery on a 1 to 7 scale: 1 = strongly prefer in clinic, 2 = moderately prefer in clinic, 3 = slightly prefer in clinic, 4 = no preference, 5 = slightly prefer at home, 6 = moderately prefer at home, 7 = strongly prefer at home. Patients who receive any care in the mobile unit will be instructed to consider "at home" to mean receipt of care inside their home or near their home in the mobile unit.
Adverse Events Related to Location of Treatment
时间窗: Up to 9 months
Safety of at-home administration of cancer treatment will be assessed by incidence of grade 3+ adverse events at least possibly related to the location of cancer treatment delivery that occur up to 30 days after the administration of the last dose of study drug/agent or therapy. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Incidence of avoidable acute care visits, emergency room visits, and hospitalizations
时间窗: Up to 24 weeks
Safety of at-home administration of cancer treatment will be assessed by the frequency and proportion of patients who experience an avoidable (in the opinion of the treating physician) acute care visit, emergency room visit, or hospitalization while receiving at-home cancer treatment.
次要结局
- Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17(Baseline, week 12, and week 24)
- Patient-reported Symptoms - PRO-CTCAE(At baseline, week 12, and week 24)
- Patient-reported Symptoms - FACT GP5(Baseline, week 12, and week 24)
- Patient-reported Satisfaction - Patient Satisfaction & Feedback(12 weeks, 24 weeks)
- Change in Patient-reported Function - EORTC-QLQ-F17(Baseline, week 12, and week 24)
- Patient-reported Satisfaction - Was It Worth It(12 weeks, 24 weeks)