The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Cancer Therapeutic Procedure
  Receive in-home standard of care cancer-treatment
• Препарат Cancer Therapeutic Procedure
  Receive in-clinic standard of care cancer-treatment
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Patient preferences regarding location of cancer treatment delivery [Срок оценки: At 12 weeks]
• Adverse Events Related to Location of Treatment [Срок оценки: Up to 9 months]
• Incidence of avoidable acute care visits, emergency room visits, and hospitalizations [Срок оценки: Up to 24 weeks]

Вторичные конечные точки (6)

• Change in Patient-reported Function - EORTC-QLQ-F17 [Срок оценки: Baseline, week 12, and week 24]
• Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17 [Срок оценки: Baseline, week 12, and week 24]
• Patient-reported Symptoms - PRO-CTCAE [Срок оценки: At baseline, week 12, and week 24]
• Patient-reported Symptoms - FACT GP5 [Срок оценки: Baseline, week 12, and week 24]
• Patient-reported Satisfaction - Patient Satisfaction & Feedback [Срок оценки: 12 weeks, 24 weeks]
• Patient-reported Satisfaction - Was It Worth It [Срок оценки: 12 weeks, 24 weeks]

Критерии участия

Критерии включения

• 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
• Biliary
• Bladder
• Breast
• Cervical
• Colorectal
• Endometrial
• Fallopian tube
• Gastroesophageal
• Glioblastoma
• Head and neck
• Hepatocellular
• Hodgkin lymphoma
• Lung
• Mantle cell lymphoma
• Merkle cell carcinoma
• Multiple myeloma
• Melanoma
• Myelodysplastic syndrome
• Ovarian
• Pancreatic
• Peritoneal
• Prostate
• Renal cell carcinoma
• Squamous cell carcinoma
• Urothelial carcinoma
• Eligible regimens

• Atezolizumab +/- bevacizumab
• Avelumab
• 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
• Zoledronic acid (Zometa)
• Willingness to follow birth control requirements for females and males of reproductive potential
• Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network
• Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic
• Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for >= 12 weeks from the time of registration
• Provide written informed consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT07285044 · MC250902 · 25-003171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗