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Terapia diretta contro il cancro a casa contro in clinica per il trattamento di pazienti con cancro avanzato, Cancer CARE Beyond Walls

4 novembre 2026 aggiornato da: Mayo Clinic

Cancer CARE Beyond Walls - Un pilota di una sperimentazione pragmatica e randomizzata di somministrazione della terapia diretta contro il cancro nelle case dei pazienti rispetto alla clinica

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

IIa. The proportion of patients who indicate a preference for home infusion or no preference versus outpatient infusion unit administration of cancer treatment as assessed via the Patient Preference Questionnaire; IIb. The proportion of patients who indicate comfort (quite a bit or very much) with receiving infusions at home as assessed by the Patient Preference Questionnaire.

III. To describe other patient experience questions within the Patient Preference Questionnaire after 24 weeks of treatment.

IV. To describe whether patients felt that infusions at home was worthwhile, would do it again, and recommend it to others after 24 weeks of treatment using the Was It Worth It questionnaire.

V. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported function and global health/quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Function 17-Item (EORTC QLQ-F17) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VI. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported symptoms as measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VII. To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment when administered at home by a home health provider with remote patient monitoring and Command Center support, based on the incidence, nature, severity, and attribution to the location of cancer care of the following:

VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), particularly those possibly, probably, or definitely related to the location of cancer care (i.e., at home versus in clinic).

VIII. To test whether home-based virtual delivery of cancer directed therapy is superior to standard in clinic administration in the proportion of patients with an emergency room visit or hospitalization at the end of 6 months of study treatment.

IX. Overall survival.

EXPLORATORY OBJECTIVES:

I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To evaluate administration of treatment based on clinical practice data.

OUTLINE:

Patients receive at least 1 cycle of their standard of care (SOC) treatment regimen in the clinic in the absence of disease progression or unacceptable toxicity. Patients are then randomized to 1 of 2 arms.

ARM A: 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 Home Health Nurse Provider (HHNP), overseen by Mayo Clinic's home health program Cancer CARE Beyond Walls (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.

ARM B: 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.

After completion of study intervention, patients are followed for 1 year.

Tipo di studio

Interventistico

Iscrizione (Stimato)

220

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224-9980
        • Reclutamento
        • Mayo Clinic in Florida
        • Contatto:
        • Investigatore principale:
          • Roxana S. Dronca, MD
    • North Dakota
      • Grand Forks, North Dakota, Stati Uniti, 58201
        • Reclutamento
        • Altru Cancer Center
        • Contatto:
        • Investigatore principale:
          • Grant Seeger, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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
      • Liver
      • Lung
      • Lymphoma
      • Melanoma
      • Merkel Cell
      • Multiple Myeloma
      • Myelodysplastic syndrome
      • Myeloid Disorders
      • Neuroendocrine carcinoma
      • Ovarian cancer
      • Pancreatic adenocarcinoma
      • Penile carcinoma
      • Peritoneal carcinoma
      • Prostate cancer
      • Renal cell cancer
      • Sarcoma
      • 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

      • 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

      • Bortezomib + venetoclax

      • Carfilzomib

      • Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor

      • Carfilzomib + venetoclax

      • Cemiplimab

      • Cisplatin

      • Cisplatin/5-FU

      • Cisplatin/etoposide

      • Cisplatin + durvalumab

      • Cisplatin + gemcitabine

      • Cisplatin + gemcitabine + durvalumab

      • Daratumumab (+ oral [PO] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)

      • Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)

      • Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)

      • Degarelix

      • Durvalumab

      • Durvalumab + tremelimumab

      • Eribulin

      • FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)

      • Fam-trastuzumab deruxtecan

      • Fulvestrant

      • Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib

      • Gemcitabine

      • Gemcitabine + durvalumab

      • Gemcitabine + paclitaxel protein-bound

      • Goserelin acetate

      • Irinotecan

      • Irinotecan + capecitabine

      • Lanreotide

      • Leuprolide

      • Nivolumab

      • Nivolumab + cabozantinib

      • Nivolumab-relatlimab

      • Octreotide

      • Paclitaxel

      • Pembrolizumab

      • Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)

      • Pemetrexed

      • Pertuzumab

      • Pemetrexed + pembrolizumab

      • Rituximab

      • Trastuzumab + paclitaxel

      • Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)

      • Decitabine

      • These regimens can be used only if patients are receiving one of the regimens above:

        • Darbepoetin-alfa
        • Epoetin
        • Filgrastim

  • Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:

    • Zoledronic acid
    • Denosumab

  • Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent

  • Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.

  • Residing within the area serviced by supplier and paramedic network

  • Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution

  • Age >= 18 years at time of registration

  • Signed informed consent form by patient

  • Willing and able to comply with the study protocol in the investigator's judgement

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

  • Ability to complete questionnaire(s) by themselves or with assistance

  • RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Quality-of-Life Assessment

Ancillary studies

Altri nomi:
  • Valutazione della qualità della vita
Altro: Questionnaire Administration

Ancillary studies

Altro: Home Health Encounter

Receive at-home treatment

Altri nomi:
  • HH
  • Casa
  • Visita di assistenza domiciliare
  • Casa Salute
Sperimentale: 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.
Altro: Quality-of-Life Assessment

Ancillary studies

Altri nomi:
  • Valutazione della qualità della vita
Altro: Questionnaire Administration

Ancillary studies

Altro: Home Health Encounter

Receive at-home treatment

Altri nomi:
  • HH
  • Casa
  • Visita di assistenza domiciliare
  • Casa Salute
Procedura: Clinical Encounter

Receive treatment in clinic

Altri nomi:
  • Incontro paziente

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean patient-reported rating of Cancer Connected Access and Remote Expertise
Lasso di tempo: 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.
At 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-preferred treatment location
Lasso di tempo: At 24 weeks

The proportion of patients who preferred care at home or expressed no preference will be computed and compared to 50% using a one-group test of proportions. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.
At 24 weeks
Patient level of comfort with receiving infusions at home
Lasso di tempo: At 24 weeks

Patient responses to comfort level with receiving infusions at home will be described using frequencies and relative frequencies. The proportion of patients who express comfort (quite a bit or very much) will also be tabulated and a proportion greater than 70% will signify acceptance. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.
At 24 weeks
Patient-reported worthwhileness
Lasso di tempo: At 24 weeks

Measured by the Was it Worth It questionnaire. The Was It Worth It questionnaire asks patients whether they thought that receiving chemo/infusions at home was worthwhile, whether they would do it again, and whether they would recommend it to others.
At 24 weeks
Patient-reported function
Lasso di tempo: At 8 weeks

Measured by the European Organization for Research and Treatment of Cancer. Mean and standard deviation of each scale will be computed by arm. Means and standard deviations of each scale will also be computed at all other assessment time points. Mean changes from baseline in each scale at 8 weeks (and other assessment time points) will be compared between arms using a linear combination of parameters from a general linear mixed model. Each model will include all available data from all time points. Fixed effects will include arm, time point, and arm-by-time point interaction. Repeated observations by patient will be modeled using compound symmetric correlation structure over time. Such values as the mean change from baseline at 8 weeks by arm, and difference in mean change from baseline at 8 weeks between arms will be estimated with confidence intervals based on the mixed model. Comparisons at other time points will also be carried out and graphically displayed using mean plots.
At 8 weeks
Patient-reported symptoms
Lasso di tempo: At 8 weeks

Will be measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (CTCAE) and summarized using composite grades. The baseline adjustment approach will be applied and resulting maximum baseline-adjusted grade will be reported by symptomatic adverse events (AE) as the proportion of patients with at least one grade >=1 AE during the first 8 weeks. The proportion of patients with at least one grade >= 3 AE per symptomatic AE will also be tabulated during the first 8 weeks. Comparisons between arms will employ Fisher's exact tests. Additional summaries over the 24 weeks by tables and graphics will also be generated.
At 8 weeks
Patient-reported side effect impact
Lasso di tempo: At 8 weeks

Will be measured by the General Physical-5 (GP5). The frequency and relative frequency of patient responses to the GP5 at 8 weeks will be computed by arm and compared between arms using a chi-squared test. The categorical analysis will also be computed at other assessment time points. Mean GP5 scores over time will also be explored using a general linear mixed model and mean plots.
At 8 weeks
Incidence of adverse events
Lasso di tempo: Up to 24 weeks

The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. The frequency and percentage of grade 3+ adverse events (by individual AEs and overall) will be reported by arm and compared between arms using a Fisher's exact test.
Up to 24 weeks
Emergency room visits and hospitalizations
Lasso di tempo: At 8 weeks

The proportion of patients with an emergency room visit or hospitalization will be computed per arm and compared between arms using a Fisher's exact test. In subsequent analyses, emergency room visits and hospitalizations will be explored separately. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.
At 8 weeks
Overall survival
Lasso di tempo: The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention

Will be estimated using the Kaplan-Meier method and compared between arms using a log-rank test.
The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mayo Clinic

Investigatori

  • Investigatore principale: Roxana S. Dronca, MD, Mayo Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 settembre 2023

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

22 marzo 2028

Date di iscrizione allo studio

Primo inviato

24 luglio 2023

Primo inviato che soddisfa i criteri di controllo qualità

24 luglio 2023

Primo Inserito (Effettivo)

1 agosto 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MC220709
  • 23-001719 (Altro identificatore: Mayo Clinic Institutional Review Board)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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