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

NCT ID: NCT07285044

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-18
• Study Completion Date: 2026-12-18

Brief Summary

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.

Conditions

Amyloidosis; Basal Cell Carcinoma; Biliary Tract Carcinoma; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Fallopian Tube Carcinoma; Gastroesophageal Junction Carcinoma; Glioblastoma; Head and Neck Carcinoma; Hematopoietic and Lymphatic System Neoplasm; Hepatocellular Carcinoma; Hodgkin Lymphoma; Lung Carcinoma; Malignant Solid Neoplasm; Mantle Cell Lymphoma; Melanoma; Merkel Cell Carcinoma; Multiple Myeloma; Myelodysplastic Syndrome; Ovarian Carcinoma; Pancreatic Carcinoma; Primary Peritoneal Carcinoma; Prostate Carcinoma; Renal Cell Carcinoma; Squamous Cell Carcinoma; Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cancer Therapeutic Procedure

Intervention Type: DRUG

Receive in-home standard of care cancer-treatment

Cancer Therapeutic Procedure

Intervention Type: DRUG

Receive in-clinic standard of care cancer-treatment

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Cancer Therapeutic Procedure

Receive in-home standard of care cancer-treatment

Intervention Type: DRUG

Cancer Therapeutic Procedure

Receive in-clinic standard of care cancer-treatment

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

anticancer therapy; Cancer Therapy; Cancer Treatment; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; anticancer therapy; Cancer Therapy; Cancer Treatment; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment

Eligibility Criteria

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.

• 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
• Leuprolide
• Nivolumab
• Nivolumab + relatlimab
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roxana S. Dronca, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: mayocliniccancerstudies@mayo.edu

Facility Contacts

Clinical Trials Referral Office

Role: primary

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2025-08758

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-003171

Identifier Type: OTHER

Identifier Source: secondary_id

MC250902

Identifier Type: OTHER

Identifier Source: secondary_id

MC250902

Identifier Type: -

Identifier Source: org_study_id