ClinicalTrials.gg
RecruitingNCT07285044Updated Sep 30, 2026

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 interventional study of Cancer Therapeutic Procedure and Cancer Therapeutic Procedure in Amyloidosis, Basal Cell Carcinoma and Biliary Tract Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Updated Sep 30, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Amyloidosis by Mayo Clinic — 3 open to participants now, 4 under way, none of them phase 3. Amyloidosis · Mayo Clinic.

Started
2025
with 2 others
Phase 2
3 of 11
1 open now
Registered
11th of 11
by date

Among the 11 studies in Amyloidosis by Mayo Clinic, this one is one of 3 that started in 2025, is one of 3 in phase 2, and was the 11th registered.

Amyloidosis

290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.

Browse Amyloidosis studies →

Open to participants now

3 of the 11 studies in Amyloidosis by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 70 Amyloidosis studies recruiting now, 43 (61%) set no upper age limit and 3 (4%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Amyloidosis by Mayo Clinic, or all of them as a file.
02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no 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
  • (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 confirmed 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 requirements for females and males of
  • 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
  • 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

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 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)
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Cancer Therapeutic Procedure · Other: Questionnaire Administration

Interventions

  • DrugCancer Therapeutic Procedure

    Receive in-home standard of care cancer-treatment

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

  • DrugCancer Therapeutic Procedure

    Receive in-clinic standard of care cancer-treatment

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

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 24 weeks

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 weeks, 24 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for May 2027, 16 months after the start.

Of 24 phase 2 interventional studies under Amyloidosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 64. This study's planned 16 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Dec 2026 → May 2027 and completion Dec 2026 → May 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2025
First posted
Dec 16, 2025
StartActual
Dec 18, 2025
Primary completionEst.
May 15, 2027was Dec 2026
CompletionEst.
May 15, 2027was Dec 2026
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Dec 18, 2026→May 15, 2027
Sep 30, 2026
Study completion
Dec 18, 2026→May 15, 2027
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Primary completion Dec 18, 2026→May 15, 2027
    Study completion Dec 18, 2026→May 15, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07285044
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Dec 18, 2025
Primary completion
May 15, 2027 (estimated)
Completion
May 15, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Roxana S. Dronca, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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