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Recruiting

NCT Number: NCT07285044

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

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.

Recruiting

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Key information

Conditions

Amyloidosis Adenocarcinoma Adnexal Diseases Astrocytoma Basal Cell Carcinoma Biliary Tract Carcinoma Bladder Carcinoma Blood Protein Disorders Bone Marrow Diseases Breast Carcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Basal Cell Carcinoma, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Cardiovascular Diseases Cervical Carcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Carcinoma Endometrial Neoplasms Fallopian Tube Carcinoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroesophageal Junction Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Gonadal Disorders Head and Neck Carcinoma Hematologic Diseases Hematopoietic and Lymphatic System Neoplasm Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hepatocellular Carcinoma Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Malignant Solid Neoplasm Mantle Cell Lymphoma Melanoma Merkel Cell Carcinoma Metabolic Diseases Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nutritional and Metabolic Diseases Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Polyomavirus Infections Primary Peritoneal Carcinoma Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Proteostasis Deficiencies Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma Thoracic Neoplasms Tumor Virus Infections Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Roxana S. Dronca, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cancer Therapeutic Procedure

Drug

Receive in-home standard of care cancer-treatment

Other names: anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy, Malignant Neoplasm Treatment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Patient preferences regarding location of cancer treatment delivery

    Time frame: 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.

  2. Adverse Events Related to Location of Treatment

    Time frame: 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.

  3. Incidence of avoidable acute care visits, emergency room visits, and hospitalizations

    Time frame: 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.

Secondary outcomes

  1. Change in Patient-reported Function - EORTC-QLQ-F17

    Time frame: 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.

  2. Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17

    Time frame: 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.

  3. Patient-reported Symptoms - PRO-CTCAE

    Time frame: 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.

  4. Patient-reported Symptoms - FACT GP5

    Time frame: 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.

  5. Patient-reported Satisfaction - Patient Satisfaction & Feedback

    Time frame: 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.

  6. Patient-reported Satisfaction - Was It Worth It

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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