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New treatment option for Amyloidosis
Official title 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
ClinicalTrials.gov ID: NCT07285044
What this study is testing
What is Cancer Therapeutic Procedure?
Cancer Therapeutic Procedure is an investigational medicine, being studied as a potential treatment for amyloidosis.
Also referred to as anticancer therapy, Cancer Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient has had adequate side effects of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically...
- Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical...
- 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
You likely can't join if
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for...
- 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...
- Individuals who require continuous (24/7) assistance with daily living and are unable to independently manage the technology required for study...
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
See the full eligibility criteria
- Patient has had adequate side effects 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...
- 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...
- 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...
- 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...
- 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)
- 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...
- 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...
- 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...
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.