Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
3.1 Registration – Inclusion Criteria
3.11 Prior treatment: 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.
3.12 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) FDA-approved for the participant’s disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.
3.13 A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program.
3.14 ECOG Performance Status (PS) 0, 1, 2 or 3 at the discretion of the treating physician. (Appendix I)
Female or male patients age ≥18 years at the time of consent
3.16 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 in Table 1.
Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed in Table 1. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified in Table 1. Co-administration with hormonal agents such as anti-androgens, PARP inhibitors, oral GnRh antagonists, estrogens, SERMs, or aromatase inhibitors are allowed, howevercombinations of oral regimens only are not permitted. Patients may receive any combination of any above listed medications or regimens in Table 1.
3.17 Willingness to follow birth control requirements for females and males of reproductive potential (see section 9.3 on Contraception)
3.18 Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network.
3.19 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
3.20 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.
3.21 Provide written informed consent
3.22 Ability to complete questionnaire(s) by themselves or with assistance.
3.23 Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
3.2 Pre-Registration – Exclusion criteria
3.24 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
3.25 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 non-oncologic 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 above are considered eligible for this trial.
3.26 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.
3.27 Current inpatient hospitalization (excluding admission to the Advanced Care at Home program).