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

NCT07285044 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC250902NCI-2025-0875825-003171
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Patient preferences regarding location of cancer treatment delivery

  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

  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

  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

Secondary Outcomes (6)

• Change in Patient-reported Function - EORTC-QLQ-F17

  Baseline, week 12, and week 24

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

  Baseline, week 12, and week 24

• Patient-reported Symptoms - PRO-CTCAE

  At baseline, week 12, and week 24

• Patient-reported Symptoms - FACT GP5

  Baseline, week 12, and week 24

• Patient-reported Satisfaction - Patient Satisfaction & Feedback

  12 weeks, 24 weeks

Study Arms (1)

Health services research (CCBW in-home cancer treatment)

EXPERIMENTAL

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.

Drug: Cancer Therapeutic Procedure; Other: Questionnaire Administration

Interventions

Cancer Therapeutic Procedure DRUG

Receive in-home standard of care cancer-treatment

Also known as: anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy, Malignant Neoplasm Treatment

Health services research (CCBW in-home cancer treatment)

Questionnaire Administration OTHER

Ancillary studies

Health services research (CCBW in-home cancer treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Amyloidosis; Carcinoma, Basal Cell; Urinary Bladder Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Glioblastoma; Carcinoma, Hepatocellular; Hodgkin Disease; Lung Neoplasms; Lymphoma, Mantle-Cell; Melanoma; Carcinoma, Merkel Cell; Multiple Myeloma; Myelodysplastic Syndromes; Ovarian Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms; Carcinoma, Renal Cell; Carcinoma, Squamous Cell; Carcinoma, Transitional Cell

Interventions

Antineoplastic Protocols

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Fallopian Tube Diseases; Adnexal Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Adenocarcinoma; Liver Neoplasms; Liver Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Bone Marrow Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Kidney Neoplasms; Kidney Diseases; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Clinical Protocols; Therapeutics; Drug Therapy; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Roxana S. Dronca, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)