- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07285044
El Programa de Acceso Conectado al Cáncer y Experiencia Remota Más Allá de los Muros para Proporcionar Tratamiento Oncológico en el Hogar y Mejorar la Satisfacción del Tratamiento en Pacientes Oncológicos que Viven en el Panhandle de Florida y Zonas Aledañas
Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Ensayo piloto de Fase 2 para evaluar la administración de terapias dirigidas contra el cáncer en los hogares de los pacientes versus en la clínica en el Panhandle de Florida y áreas circundantes
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.
Descripción general del estudio
Estado
Condiciones
- Neoplasia Sólida Maligna
- Melanoma
- Carcinoma de células renales
- Glioblastoma
- Mieloma múltiple
- Carcinoma hepatocelular
- Linfoma de Hodgkin
- Amilosis
- Linfoma de células del manto
- Carcinoma de mama
- Síndrome mielodisplásico
- Carcinoma de las trompas de Falopio
- Carcinoma de cuello uterino
- Carcinoma endometrial
- Carcinoma urotelial
- Carcinoma de cabeza y cuello
- Carcinoma de pulmón
- Carcinoma de células de Merkel
- Carcinoma colorrectal
- Carcinoma de ovario
- Carcinoma de vejiga
- Carcinoma de páncreas
- Carcinoma de próstata
- Carcinoma de células basales
- Carcinoma Peritoneal Primario
- Carcinoma de células escamosas
- Carcinoma de vías biliares
- Carcinoma de la unión gastroesofágica
- Neoplasia hematopoyética y del sistema linfático
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
Ubicaciones de estudio
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Florida
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Jacksonville, Florida, Estados Unidos, 32224-9980
- Reclutamiento
- Mayo Clinic in Florida
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Contacto:
- Clinical Trials Referral Office
- Número de teléfono: 855-776-0015
- Correo electrónico: mayocliniccancerstudies@mayo.edu
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Investigador principal:
- Roxana S. Dronca, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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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
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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
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A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician
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Female or male patients age >= 18 years at the time of consent
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Willing and able to comply with the study protocol in the investigator's judgement
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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.
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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
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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
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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)
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Willingness to follow birth control requirements for females and males of reproductive potential
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Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network
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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
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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
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Provide written informed consent
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Ability to complete questionnaire(s) by themselves or with assistance
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Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Exclusion Criteria:
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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
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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
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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
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Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
Ancillary studies Receive in-home standard of care cancer-treatment
Otros nombres:
Receive in-clinic standard of care cancer-treatment
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient preferences regarding location of cancer treatment delivery
Periodo de tiempo: At 12 weeks
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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. |
At 12 weeks
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Adverse Events Related to Location of Treatment
Periodo de tiempo: Up to 9 months
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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. |
Up to 9 months
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Incidence of avoidable acute care visits, emergency room visits, and hospitalizations
Periodo de tiempo: Up to 24 weeks
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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. |
Up to 24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Patient-reported Function - EORTC-QLQ-F17
Periodo de tiempo: Baseline, week 12, and week 24
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Assessed using the 15 function-related questions from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-F17. The F17 is an abbreviated version of the EORTC-QLQ-C30 questionnaire (30 questions), which is used to assess the quality of life of cancer patients. The F17 is composed solely of items related to function. It also includes two questions related to health status and quality of life (QOL). Fifteen function questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4= very much), and two health/QOL questions are answered on a scale of 1-7 where 1= very poor and 7=excellent. Higher summary scores indicate greater overall function and better health related quality of life. |
Baseline, week 12, and week 24
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Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17
Periodo de tiempo: Baseline, week 12, and week 24
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Assessed by two questions from the EORTC-QLQ-F17 related to Global Health Status/Quality of Life (QL) scale. These questions are answered on a scale of 1-7 where 1= very poor and 7=excellent. Higher summary scores indicate better health related quality of life. |
Baseline, week 12, and week 24
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Patient-reported Symptoms - PRO-CTCAE
Periodo de tiempo: At baseline, week 12, and week 24
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As measured by the Patient Reported Outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE scores will be summarized using composite scores. The PRO-CTCAE was developed to assess patient self-reported symptoms in cancer clinical trials. The PRO-CTCAE consists of 27 questions related to symptoms and side effects experienced over the past 7 days. Each question is answered on a 5-point scale (e.g., none/mild/moderate/severe/very severe or never/rarely/occasionally/frequently/almost constantly). The final question is an opportunity to list any other symptoms not included in the assessment. Higher scores indicate experience of worse or more frequent/severe symptoms and side effects. |
At baseline, week 12, and week 24
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Patient-reported Symptoms - FACT GP5
Periodo de tiempo: Baseline, week 12, and week 24
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As measured by the Functional Assessment of Cancer Therapy General 5 (FACT GP 5), a single question evaluating how much participants were bothered by treatment side effects over the past 7 days. The question is answered on a scale of 0-4, where 0=not at all, 1=a little bit, 2-somewhat, 3-quite a bit, and 4=very much. |
Baseline, week 12, and week 24
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Patient-reported Satisfaction - Patient Satisfaction & Feedback
Periodo de tiempo: 12 weeks, 24 weeks
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As measured by the Patient Satisfaction and Feedback Questionnaire developed for this study. Patient responses will be summarized descriptively. The frequency and proportion of patients who express comfort receiving their cancer treatment at home (i.e., response of "quite a bit" or "very much") will be reported. |
12 weeks, 24 weeks
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Patient-reported Satisfaction - Was It Worth It
Periodo de tiempo: 12 weeks, 24 weeks
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As measured by the 6-item Was It Worth It Questionnaire, which asks patients whether they thought that receiving cancer care at home was worthwhile, whether they would do it again, and whether they would recommend it to others. The patient is also asked whether care at home changed their quality of life and whether the experience was as expected. The patient will also have an opportunity to provide a free-text response about anything they recommend be changed to improve their experience. Responses will be summarized descriptively. |
12 weeks, 24 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Roxana S. Dronca, MD, Mayo Clinic
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades metabólicas
- Enfermedades intestinales
- Enfermedades del sistema inmunológico
- Infecciones
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Enfermedades pulmonares
- Enfermedades hematológicas
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Enfermedades del HIGADO
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Hepaticas
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Enfermedades del Colon
- Infecciones por virus de ADN
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Neoplasias Urológicas
- Carcinoma
- Neoplasias De Células Escamosas
- Enfermedades del cuello uterino
- Astrocitoma
- Glioma
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Linfoma
- Enfermedades de la médula ósea
- Neoplasias Renales
- Neoplasias Uterinas
- Tumores neuroendocrinos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Infecciones por virus tumorales
- Nevos y Melanomas
- Neoplasias De La Piel
- Enfermedades de la vejiga urinaria
- Deficiencias de proteostasis
- Infecciones por poliomavirus
- Enfermedades de las trompas de Falopio
- Neoplasias Basocelulares
- Carcinoma Neuroendocrino
- Enfermedades Nutricionales y Metabólicas
- Enfermedades de la piel y del tejido conectivo
- Enfermedades hemic y linfáticas
- Neoplasias prostáticas
- Carcinoma Hepatocelular
- Neoplasias Pulmonares
- Neoplasias colorrectales
- Neoplasias Ováricas
- Neoplasias de mama
- Carcinoma De Células Escamosas
- Neoplasias pancreáticas
- Glioblastoma
- Carcinoma De Célula Renal
- Neoplasias del cuello uterino
- Mieloma múltiple
- Melanoma
- Síndromes mielodisplásicos
- Enfermedad de Hodgkin
- Neoplasias de la vejiga urinaria
- Neoplasias Endometriales
- Amilosis
- Carcinoma De Células De Transición
- Carcinoma Basocelular
- Neoplasias de las trompas de Falopio
- Carcinoma De Células De Merkel
- Linfoma De Células Del Manto
- Calidad, acceso y evaluación de la atención médica
- Terapéutica
- Terapia con drogas
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Características del estudio epidemiológico
- Protocolos clínicos
- Protocolos antineoplásicos
Otros números de identificación del estudio
- MC250902
- 25-003171 (Otro identificador: Mayo Clinic Institutional Review Board)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .