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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

29 de septiembre de 2026 actualizado por: Mayo Clinic

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

Tipo de estudio

Intervencionista

Inscripción (Estimado)

27

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224-9980
        • Reclutamiento
        • Mayo Clinic in Florida
        • Contacto:
        • Investigador principal:
          • Roxana S. Dronca, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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:
  • terapia contra el cáncer
  • Terapia contra el cáncer
  • Tratamiento contra el cáncer
  • Terapia con neoplasia maligna
  • Tratamiento de neoplasma maligno

Receive in-clinic standard of care cancer-treatment

Otros nombres:
  • terapia contra el cáncer
  • Terapia contra el cáncer
  • Tratamiento contra el cáncer
  • Terapia con neoplasia maligna
  • Tratamiento de neoplasma maligno

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient preferences regarding location of cancer treatment delivery
Periodo de tiempo: 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.

At 12 weeks
Adverse Events Related to Location of Treatment
Periodo de tiempo: 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.

Up to 9 months
Incidence of avoidable acute care visits, emergency room visits, and hospitalizations
Periodo de tiempo: 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.

Up to 24 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Patient-reported Function - EORTC-QLQ-F17
Periodo de tiempo: Baseline, week 12, and week 24

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
Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17
Periodo de tiempo: Baseline, week 12, and week 24

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
Patient-reported Symptoms - PRO-CTCAE
Periodo de tiempo: At baseline, week 12, and week 24

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
Patient-reported Symptoms - FACT GP5
Periodo de tiempo: Baseline, week 12, and week 24

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
Patient-reported Satisfaction - Patient Satisfaction & Feedback
Periodo de tiempo: 12 weeks, 24 weeks

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
Patient-reported Satisfaction - Was It Worth It
Periodo de tiempo: 12 weeks, 24 weeks

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Roxana S. Dronca, MD, Mayo Clinic

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de diciembre de 2025

Finalización primaria (Estimado)

15 de mayo de 2027

Finalización del estudio (Estimado)

15 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

9 de diciembre de 2025

Publicado por primera vez (Actual)

16 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

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)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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