In-home cancer treatment with remote specialist support for patients in the Florida Panhandle
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
This program will try giving standard cancer treatments at home to people living in the Florida Panhandle and nearby areas to see if they prefer it and have better treatment satisfaction.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, Atezolizumab, bevacizumab, Avelumab, Cemiplimab, Daratumumab, Denosumab, Durvalumab, relatlimab, Pertuzumab, trastuzumab, immunotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07285044 on ClinicalTrials.gov |
What this trial studies
The phase II CARE Beyond Walls program delivers FDA-approved or guideline-recommended cancer therapies in patients' homes using a specialized home health team connected remotely with Mayo Clinic providers. Participants must be tolerating their current standard-of-care regimens and pass a social stability screener before enrollment. The intervention includes home administration of cancer therapeutic procedures and repeated questionnaires to measure treatment satisfaction and patient preference compared with traditional clinic care. Care is coordinated through Mayo Clinic in Florida and limited to patients living in the Florida Panhandle and surrounding areas.
Who should consider this trial
Good fit: Ideal candidates are medically stable cancer patients living in the Florida Panhandle or nearby areas who are tolerating their current standard-of-care treatments and meet the program's social stability requirements.
Not a fit: Patients who are medically unstable, have recent clinically significant drug-related reactions, require inpatient or complex clinic-based procedures, or live outside the program's service area are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce travel and disruption for patients, increase convenience and treatment satisfaction, and expand access to supportive oncology care at home.
How similar studies have performed: Other home-based oncology and home-infusion programs have reported improved patient satisfaction in observational series, but randomized or controlled phase II evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Roxana S. Dronca, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.