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
| NCT ID | NCT07285044 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 27 participants in total. It began in 2025-12-18 with a primary completion date of 2026-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. 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)
Contact & Investigator
Roxana S. Dronca, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07285044 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07285044 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07285044 currently recruiting?
Yes, NCT07285044 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT07285044 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07285044 clinical trial?
NCT07285044 is sponsored by Mayo Clinic. The principal investigator is Roxana S. Dronca, MD at Mayo Clinic. The trial plans to enroll 27 participants.