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AmyloidosisPhase 2NCT07285044

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

A Phase 2 study testing Cancer Therapeutic Procedure and Questionnaire Administration in people with Amyloidosis and Basal Cell Carcinoma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cancer Therapeutic Procedure and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
18 Dec 2025to 15 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 67Show fewer
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Roxana S. Dronca, MD

    Recruiting

Other trials in United States

About this study

Official 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

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.

Being tested
Cancer Therapeutic Procedure, Questionnaire Administration
Medical subject headings
Amyloidosis, Carcinoma, Basal Cell, Urinary Bladder Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cancer Therapeutic ProcedureDrug

    Also called anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy

    Receive in-home standard of care cancer-treatment

  • Cancer Therapeutic ProcedureDrug

    Also called anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy

    Receive in-clinic standard of care cancer-treatment

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07285044
Study groupRoleWhat they receive
Health services research (CCBW in-home cancer treatment)ExperimentalPatients 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.
Receives: Drug: Cancer Therapeutic Procedure; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 weeks

  2. 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.

    Measured: Up to 9 months

  3. 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.

    Measured: Up to 24 weeks

Secondary outcomes (6)

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

    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.

    Measured: Baseline, week 12, and week 24

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

    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.

    Measured: Baseline, week 12, and week 24

  3. Patient-reported Symptoms - PRO-CTCAE

    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.

    Measured: At baseline, week 12, and week 24

  4. Patient-reported Symptoms - FACT GP5

    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.

    Measured: Baseline, week 12, and week 24

  5. Patient-reported Satisfaction - Patient Satisfaction & Feedback

    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.

    Measured: 12 weeks, 24 weeks

  6. Patient-reported Satisfaction - Was It Worth It

    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.

    Measured: 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start18 Dec 2025
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285044
Sponsor's protocol ID
MC250902
Other IDs
25-003171
Status last verified
Sep 2026
First submitted
9 Dec 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cancer Therapeutic Procedure and Questionnaire Administration in people with Amyloidosis and Basal Cell Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 67 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient preferences regarding location of cancer treatment delivery (time frame: At 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07285044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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Clinical Trial NCT07285044 | AzTrials