Eligible participants will be asked to sign a separate consent form for this optional study at the time they are enrolling on SJMB; participants will then be randomly assigned to either the standard-of-care control group or the exercise intervention group
Eligible participants will be asked to sign a separate consent form for this optional study; participants will then be randomly assigned to either the standard-of-care control group or the Cogmed computerized intervention group
Supportive care and other medications that are considered necessary for the subjects wellbeing may be given at the discretion of the investigator
For sites with the B pharmaceutical trial open, precursor B-cell ALL patients from that site may be eligible for S providing they meet the following criteria:\r\n* Patient is in second salvage or more and B has been considered and ruled out as a treatment option; OR\r\n* Patient was treated on the standard of care arm of B and failed therapy
Patients who are women of childbearing potential must have a negative pregnancy test documented =< days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of care
Progressed following all standard of care therapies for advanced breast cancer. OR
Patients must be candidates for standard of care treatment consisting of chemotherapy (cisplatin) and radiation
Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
History of two or more episodes of acute chest syndrome (ACS) in the -year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy);
Demonstrated lack of compliance with prior medical care as determined by referring physician.
Have documented relapse or refractoriness after at least line (MB and ARMS subjects) or lines (NB and ES subjects) of standard-of-care therapy, including each of the following:
Histologically-diagnosed, advanced Gl tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Dose Expansion Phase)
Histologically-diagnosed advanced colorectal tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Phase b)
Demonstrated lack of compliance with prior medical care
Patients must have histological diagnosis of melanoma or non-small cell lung cancer (biopsy will be done per standard of care, if needed to prove metastatic melanoma and/or NSCLC as well as for clinically relevant mutation analysis); additional biopsy will be per standard of care
All melanoma patients may be tested for BRAF as part of routine standard of care, but is not a requirement for the trial; all NSCLC patients may be tested for with EGFR and ALK as part of standard of care, but is not a requirement of the trial
Patients must have previously received and progressed on standard-of-care therapy(ies).
CMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatment
Subject has any evidence of metastatic disease (pre-operative staging will be undertake per urologic standard of care) as deemed by the Investigator
Must have received appropriate standard of care
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for the care of the patient.
Any cancer-related therapy for the current disease within weeks of screening (all supportive care measures are allowed)
Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
Must have refused standard of care chemotherapy for metastatic disease
Patients must be considered candidates for prostatectomy as per standard of care
Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation
ARM I INCLUSION CRITERIA: Subject is eligible for and agrees to receive standard of care stereotactic radio surgery with or without prior neuro-surgical intervention
ARM II INCLUSION CRITERIA: Subject is eligible for and agrees to receive standard of care radiation and temozolamide after biopsy or maximum safe surgical resection
Lack of insurance coverage or funding to support cost of care.
Prior treatment with sipuleucel-T (on clinical trial or as part of standard of care)
Inability to follow standard of care follow up recommendations per investigator discretion
Demonstrated lack of compliance with prior medical care
The patient must have completed chemoradiation with radiation therapy and temozolomide of the primary tumor according to standards of care
Subject meets standard of care eligibility criteria for consideration of treatment with immunotherapy using a checkpoint inhibitor following surgical resection
Any cancer-related therapy for the current disease within weeks of screening (all supportive care measures are allowed)
Patients must have progressive tumor growth after having received established standard of care treatment for their disease
Must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin that is persistent or progressive following multiple rounds of prior standard of care and experimental therapy.
Meets standard of care to undergo embolization
Diagnosed with high risk hematologic disorders warranting stem cell transplant per institutional standard of care
Follow standard of care donor eligibility procedure, outlined in the standard operation procedure (SOP)
Completion of at least one standard of care IV chemotherapy course; hematologic recovery must be confirmed prior to study entry;
Being considered for trabectedin as standard of care
Planning to undergo additional treatment for the brain tumor other than standard of care
Patients may be enrolled in any line of standard treatment (without investigational agents); the start date of current treatment should be at least two weeks or more prior to registration; (Note: patients will continue to receive the planned active treatment with chemotherapy or endocrine therapy [standard of care] and initiate denosumab at the recommended dose for this protocol)
Patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Any candidate eligible for standard of care Y radioembolization for treatment of their primary or metastatic liver tumors
Patients who would have otherwise been eligible to receive routine post-RP care
Must be eligible for treatment with nivolumab as standard of care
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of weeks of their last dose of ixazomib in the parent study or as agreed by the Millennium clinician/designee.
Recurrence or progression of disease (confirmed by MRI and measurable by RANO criteria) following receipt of standard of care therapy, which includes maximum safe surgical resection, standard adjuvant radiation/temozolomide treatment. Participants must have completed at least days of temozolomide treatment in combination with radiation therapy to be considered to have received standard of care therapy.
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Subjects must be planning to start standard of care radiation therapy and chemotherapy
Karnofsky score of % or better (requires occasional assistance, but is able to care for most of his/her needs)
Patients who are refusing first line standard of care chemotherapy
EGFR wt as per patient standard of care by a validated test
AND ALK-negative rearrangement as part of the patient standard of care by a validated test
Cancer treatment other than radiation therapy, including investigational or standard of care, within days prior to treatment with REGN
Anticoagulants < days prior to Day . Aspirin is permitted in Phase b per standard of care with lenalidomide-based therapy.
Completed all standard of care therapy (surgery + radiation as clinically necessary) prior to vaccination
Judged by investigator to have progressive disease sufficient to clinically justify standard-of-care radium- treatment
Documented progression of disease according to RECIST v. following primary standard of care (e.g. erlotinib, gefitinib) Group patients:
Documented progression of disease according to RECIST v. following standard of care (e.g. platinum doublet).
Patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
MAIN STUDY COHORT EXCLUSION CRITERIA: Pregnancy (as determined by point of care test administered in accordance with the policies of the Department of Nuclear Medicine)
RENAL CELL CARCINOMA (RCC) COHORT EXCLUSION CRITERIA: Pregnancy (as determined by point of care test administered in accordance with the policies of the Department of Nuclear Medicine)
Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations
Planned stereotactic biopsy as standard of care (i.e., for confirmation of disease progression)
Patients must be willing to receive follow-up care for a minimum of years after treatment at participating institution(s) and annual visits unless it is too difficult to return to participating institution for follow-up care; in that event, patients must be willing to have outside medical information released in order to track the results of treatment
Evidence that the tumor MGMT promoter is unmethylated by standard of care assays
Intensive care unit (ICU) care, life expectancy of less than days, ongoing or unresolved hepatic sinusoidal obstruction syndrome, unstable hemodynamics, or evidence of current or previous clinically significant disease, medical condition or finding (including vital signs and ECG) that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Health care coverage.
Patient has a desire to preserve organ, understanding the risks of delaying standard of care
Patients with planned standard of care ASCT using melphalan mg/m^
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART ): The patient PDXs must have generated informative mouse xenograft data during Part to participate in Part .
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART ): Patients should ideally have bi-dimensional measurable disease (leukemia phase only, bone marrow only, splenomegaly only, or GI involvement only is acceptable).
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART ): Patients must have adequate organ function for drugs(s) or combination being utilized (dependent on the drug (s) being given).
Part patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
For stratum A, patients must have local recurrent disease (defined as negative spine magnetic resonance imaging [MRI] and negative cytology within days prior to study registration) and undergo resection of local recurrence as part of their standard of care; children must have undergone what is considered the standard of care as upfront therapy including either surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy
ARM A: Child Pugh Score A (patients with ascites must have paracentesis performed within scope of standard of care, to be able to successfully perform intratumoral injection procedure)
Subjects must be within to weeks of standard of care treatment for their particular stage of disease
Subjects must not be more than weeks from standard of care treatment for their particular stage of disease
Demonstrated lack of compliance with prior medical care
Both patients who will and will not receive standard of care concomitant mitomycin C are eligible to enroll in this study
Eligibility for brachytherapy is determined per clinical standard of care
Contraindications to the planned second line standard-of-care chemotherapy regimen
Subjects who are eligible for further standard of care endocrine treatment.
Any evidence of metastatic disease; pre-operative staging will be undertaken per urologic standard of care
Patients in expansion cohort A will have a biopsy (which is standard of care) at the time of progression that shows evidence of MET positivity
Eligible to receive standard-of-care sorafenib
Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Eligible to receive standard of care chemotherapy and/or surgery based upon standard practices or institutional guidelines
Failure of at least one prior standard of care chemotherapy for advanced stage disease
Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR)
In countries where continuous anti-HER therapy is considered standard of care for HER- positive metastatic disease, HER- positive subjects are not eligible.
Patients must be willing to receive follow-up care for a minimum of five years after treatment at Massachusetts General Hospital (MGH) and annual visits unless it is too difficult to return to MGH for follow-up care; in that event, the patient or guardian must be willing to have their outside medical information (i.e. imaging studies, laboratory results and doctor or other health professional notes) released in order to track the results of treatment
Patients undergoing Surefire DEB-TACE procedure as clinically determined to be part of their standard of care treatment plan
Ability to elect radiotherapy care in conjunction with their physician
Patients will have cytoreductive surgery as part of their routine care for recurrent tumor
Prior to randomization, patients with metastatic disease must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
Any standard contraindications to myeloablative HSCT per standard of care practices at COH
Subjects have already undergone all standard of care surgery appropriate for stage of disease.
Zometa or denosumab can be continued as per standard of care as long as started before the study treatment is started
Patients must be on standard of care lenalidomide maintenance therapy for at least months at the time of study enrollment.
Patient must require a new pre-treatment biopsy as part of their standard of care work-up
Patient does not require a pre-treatment biopsy as part of their standard of care work- up
Patients must continue HER-targeted monoclonal antibody therapy dosing per standard of care through the entire study period (one year)\r\n* HER-targeted monoclonal antibody therapy is defined as either trastuzumab monotherapy, or trastuzumab and pertuzumab combination therapy administered per standard of care
Due to risk of disease exacerbation patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Must have established relationship with primary care physician and provide contact information
Karnofsky score of % or better (requires occasional assistance, but is able to care for most of his/her needs)
All prospective participants must have an Ommaya reservoir (or equivalent ventricular access device) inserted as part of their standard clinical care prior to initiation of study treatment
Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits; available computed tomography (CT) scans, bone scans, and labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within weeks of the first dose of AVX; available multi gated acquisition scan (MUGA), echocardiogram, and electrocardiogram (EKG) performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within weeks of the first dose of AVX
Patient is starting standard of care Gemcitabine treatment
Patients in whom surgical excision of the tumor is part of standard of care management
Been treated for early breast cancer with standard of care duration of trastuzumab.
Patients who have demonstrated relapse to or more prior regimens of SM treatment (not including those given for supportive care)
Patients must be planning to undergo standard of care treatment with surgery and radiation therapy.
ELIGIBILITY CRITERIA RECIPIENT ON STANDARD CARE THERAPY
EXCLUSION CRITERIA RECIPIENT ON STANDARD CARE THERAPY
Patient is expected to undergo autologous HPC transplantation that is consistent with standard of care
Demonstrated lack of compliance with prior medical care
Dose Escalation Phase: Have a documented diagnosis of a lymphoid hematological malignancy as described by the World Health Organization (WHO) classification that requires therapy and for which there is no standard of care or standard of care is not expected to be effective. Subjects must not be candidates for anti-tumor regimens known to provide clinical benefit. MM Dose Expansion Cohort:
Patients currently on other protease inhibitors; patients can be switched to an alternative combination antiretroviral therapy regimen, as deemed appropriate by their HIV care provider
Children not in the care or custody of a biological parent, adoptive parent, appointed legal guardian, or legally appointed foster care.
Has had within the past months the occurrence or persistence of one or more of the following medical conditions that could not be controlled with usual medical care (e.g., required emergency care or hospitalization): hypertension, angina, congestive heart failure, diabetes, seizure disorder.
Participants for whom no further standard of care therapy exists, must have received standard of care chemotherapy in the adjuvant or advanced/metastatic setting
Standard (i.e., includes at least taxane + anthracycline) NAC and definitive surgery planned; (NOTE: NAC chemotherapy will be per standard of care, and not dictated by this clinical trial)
No standard care available
PLD at the dose and schedule being used might be considered standard of care
Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
Hemodynamically stable, consistent with standard of care values for patients undergoing elective tumor resection
Patient willing to undergo scheduled standard of care TRUS guided biopsy
Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX, any topoisomerase inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.
Must have undergone biopsy after development of acquired resistance to erlotinib (which is performed as standard of care) with adequate tissue to determine EGFR TM and tumor histology; slides from an outside institution may be used
- The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS are allowed and these agents should be administered before study if available to patient according to local standards)
Arm only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
Arm only: Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum which is refractory to or has failed standard treatments, or participant is not considered medically suitable to receive standard of care treatment or refuses standard of care treatment
Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression after standard-of-care therapy including radiotherapy. Patients currently receiving steroids must have been on a stable (or decreasing) dose for at least days before initiating study therapy.
Patients must be undergoing repeat surgery that is clinically indicated as determined by their care providers
Severity of any medical illness that, in the Investigator's judgement, justifies hospitalization of the subject for treatment and supportive care
Approval for allogenic regimen given at Patient Care Conference
All patients in both group and will also be referred to radiation and medical oncology for standard of care adjuvant therapy with or without PDT therapy
The patient received induction and consolidation therapy according to the Institution's standard of care.
Patients with bilateral pulmonary metastases from sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to the lungs, mediastinum, or pleura who can be rendered no clinical evidence of active disease (NED) or minimal residual disease (MRD) by standard of care metastasectomy where NED refers to diagnostic tests failing to detect presence of disease and MRD refers to low-volume, subclinical disease which is not amenable to standard of care biopsy for histologic confirmation and poses no immediate threat to patient health and would not otherwise warrant standard of care treatment but surveillance instead
PATIENT: Receiving primary cancer care at one of the participating sites
In phase , subjects are also required on accrual to be referred to palliative care
Designated by the patient as a person closely involved in their care
CLINICAL STAFF: Nurses, physicians, physician assistants, or support staff and perform direct patient care in the thoracic oncology clinic
Had their cancer care primarily managed by either Johns Hopkins Medical Institution (JHMI) or Peninsula Regional Medical Center (PRMC), with JHMI or PRMC primarily responsible for the patients survivorship care
Did not have cancer care primarily managed within one of the participating clinics, or JHMI or PRMC is not primarily responsible for the patients survivorship care
COHORT C SPECIFIC INCLUSION: Histologically confirmed IDH mutant glioma, meningioma, or ependymoma that has recurred despite previous standard of care therapy; because this cohort is, in part, meant to allow patients access to therapy who might not otherwise be eligible for other clinical trials - deviations from standard of care treatment can be presented to and approved by the principal investigator for inclusion in the study
on maintenance standard-of-care chemotherapies or on treatment holiday
Primary cancer care at one of the three participating sites
Patients not receiving care at Massachusetts General Hospital (MGH)
Patients receiving supportive care alone
(Patient participation) First outpatient consultation visit with a palliative care specialist
Diagnosis of glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and gray (Gy) of radiation given over treatments
Are unable to walk or to complete the -minute walk test\r\n* According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe
Has a primary care provider at Columbia University Medical Center (CUMC)/New York Presbyterian (NYP)
PATIENTS: Admitted to the acute palliative care unit
PATIENTS: Patients with hematologic cancer receiving care at a participating clinic.
Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center
HSCT CLINICIANS: Member of MSKCC BMT patient care team for at least one year
Patients in the intensive care units will not be eligible
Patients already seeing pharmacy as a part of their care
Palliative Care Clinician: Current MGH palliative care clinician (board-certified physicians or mid-level practitioners)
Planning to receive care at MGH
Phase II: Patients will be excluded from participating in this research study if they:\r\n* Are already receiving palliative care in the outpatient setting\r\n* Need immediate palliative care and/or hospice care (as determined by their oncology team)\r\n* Have active, untreated, unstable, serious mental illness (e.g., active, untreated psychotic, bipolar, or substance-dependence disorder) interfering with ability to participate\r\n* Have a cognitive impairment (e.g., delirium, dementia) interfering with ability to participate
Finished with active cancer treatment within the past years and are in the survivorship phase of care
PHASE : PATIENT ELIGIBILITY: At least . years from treatment (which is a typical time for preparation to transfer to long-term follow-up care)
Identifies a DCG involved in his/her care, support, or care planning
Involved in direct patient care
Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
Admitted to Burke Services (WBG th floor) with plans for inpatient myelosuppressive chemotherapy (with standard of care or protocol regimens) (this will include induction for patients with low risk APL)
Patients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment plan
Known allergy to the standard of care or ingredients in KeraStat Cream
Patients seen in the outpatient palliative care clinic or inpatients seen by the palliative care consult team or the fatigue clinic
Patients admitted to the intensive care unit
CARE RECIPIENT:
Treatment expected to last longer than months since this will make it impossible to deliver the end of therapy survivorship care planning session within the study timelines (patient)
Admission to intensive care unit on enrollment
Prospective study: completed primary treatment for breast malignancies; receive survivorship care at Thomas Jefferson University (TJU) or Reading Health System (RHS)
Patients treated as outpatients by the supportive and palliative care team.
Previous psychological counseling received in supportive care department.
Score of >= on Patient Care Monitor Sexual Concerns screening item
Be under the care of a MCC physician
Inpatient at MD Anderson seen by palliative care team
PATIENT: Planning to receive all medical care for cancer at the enrolling institution
PATIENT: Participants must be under the care of an oncologist (who does not practice as a palliative care physician for that patient), but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies
Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan
Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
Histologic proof of HCC reviewed and confirmed per the local standard of care
Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
Caregivers: The person in the patients life who is primarily responsible for care decisions, emotionally invested in the patients care, provides instrumental care such as transportation, and available if randomized to the fPER group to participate in the majority of intervention sessions
Admitted to Acute Palliative Care Unit (APCU)
Planning to receive care at the participating institution
Participation in the study must be approved by the physician directly responsible for the patients care while at University of North Carolina (UNC)-Hospitals
Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
Immune compromised or other serious medical conditions, other than cancer diagnostic, at enrollment; immune compromised subjects will be defined as having absolute neutrophil count (ANC) less than as determined by complete blood count testing (CBD) performed weekly as standard of care in individuals receiving chemoradiation
Planned greater than one night admission to the intensive care unit (ICU)
Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
All consecutive subjects undergoing routine (standard of care) Lugols chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing subjects referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group
Reside in California or receive care at a Sanford Health site
Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
Was seen in the last months a provider at one of the primary medical care clinics from the University of: General Internal Medicine (Lowry, Anschutz), Family Medicine (Westminster, Stapleton, Park Meadows, Boulder), or the Women's Integrated Services in Health (WISH) Clinic, and the individuals primary medical care provider has provided approval for AHP CRC outreach to an AHP staff person, and have no record of a colonoscopy within the last years, flexible sigmoidoscopy or double-contrast barium enema within the past years, or fecal occult blood test (FOBT) within the past year
Health care centers
Health care centers serving low-income, Medicaid, and uninsured patients in Missouri and Illinois
Patients seen at the health care center (HC) in the preceding years
Providers at selected primary care practices in the Cleveland Clinic Health System
Referral from a primary care physician for colonoscopy (either diagnostic or screening)
All ambulatory patients taken care of by the participating pediatric hematology/oncology clinics will be eligible
FOCUS GROUP: Who are enrolled at Group Health at least one year prior to mammogram, receive care in the greater Seattle area and have had a negative mammogram (breast imaging-reporting and data system [BIRADS] or assessment) as part of their routine care within the past months
BETA/USABILITY TESTING: Who are enrolled at Group Health, receive care in the greater Seattle area and have had a negative mammogram (BIRADS assessment of or ) as part of their routine care
Participants must consent to two standard of care lower gastro-intestinal GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies that will be months (+/- days) apart.
PHASE I: MedStar Georgetown University Hospital (MGUH) pediatric primary care providers (pPCP) providers
Willingness to commit to follow-up with his/her primary care provider after completion of the Getting Ahead training program
Participants must consent to one standard of care lower gastrointestinal (GI) endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies and one flexible sigmoidoscopy with biopsies that will be months (+ days) apart
Patients will be included in the study based on the following criteria:\n\n - Women years or older\n\n - Node-positive breast cancer (AJCC N, N, or N)\n\n - Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR)\n receptors and have received chemotherapy as standard of care\n\n - Clinically cancer-free (no evidence of disease) after standard of care therapy\n (surgery, chemotherapy, radiation therapy as directed by NCCN guidelines). Hormonal\n therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.\n\n - Recovery from any toxicity(ies) associated with prior adjuvant therapy.\n\n - HER expression of + or + by IHC. FISH or Dual-ISH testing must be performed on IHC\n + tumors and shown to be non-amplified by FISH (?.) or by Dual-ISH (?.).\n\n - HLA-A, A, A, or A positive\n\n - LVEF >%, or an LVEF within the normal limits of the institution's specific testing\n (MUGA or Echo)\n\n - ECOG ,\n\n - Signed informed consent\n\n - Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral\n tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)\n\n - Must start study treatment (receive first Herceptin infusion) between - weeks\n from completion of standard of care therapy.\n\n .. Exclusion Criteria\n\n Patients will be excluded from the study based on the following criteria:\n\n - Node-negative breast cancer (AJCC N or N(i+)) unless negative for both estrogen (ER)\n and progesterone (PR) receptors and has received chemotherapy as standard of care\n\n - Clinical or radiographic evidence of distant or residual breast cancer\n\n - HER negative (IHC ) or HER + or FISHDual-ISH amplified (FISH >.); Dual-ISH >.\n\n - HLA-A, A, A, A negative\n\n - History of prior Herceptin therapy\n\n - NYHA stage or cardiac disease\n\n - LVEF <%, or less than the normal limits of the institution's specific testing (MUGA\n or Echo)\n\n - Immune deficiency disease or HIV, HBV, HCV\n\n - Receiving immunosuppressive therapy including chemotherapy, chronic steroids,\n methotrexate, or other known immunosuppressive agents\n\n - ECOG ?\n\n - Tbili >., creatinine>, hemoglobin<, platelets<,, WBC<,\n\n - Pregnancy (assessed by urine HCG)\n\n - Breast feeding\n\n - Any active autoimmune disease requiring treatment, with the exception of vitiligo\n\n - Active pulmonary disease requiring medication to include multiple inhalers\n\n - Involved in other experimental protocols (except with permission of the other study\n PI)
Agrees to Loop Electrosurgical Excision Procedure (LEEP), Cold Knife Conization (CKC) or Hysterectomy being performed at the end of study according to the standard-of-care
Patients must be undergoing surgery that is clinically indicated as determined by their care providers
Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. The washout periods from prior therapies are intended as follows:
Must have a primary care provider (PCP)
Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
Established prenatal care
Patients who have a short term CVC that have been placed in Intensive Care Unit (ICU) (mainly rigid wall CVCs placed for acute care in ICU)
Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
Radiation to the recurrent or metastatic site is clinically indicated and would be considered standard care for palliation or for locoregional control
Women who have already had their standard of care post-NAT mammogram and/or breast MRI
Lung cancer patients receiving definitive radiation therapy defined as - Gy as part of standard of care for their disease
Patient must be expected to undergo therapy with bevacizumab in combination with paclitaxel at recommended standard of care doses if suspected recurrence is confirmed with imaging
Planned standard of care surgery
Patients scheduled for Y radioembolization for HCC as part of their standard of care
Suspicion of gynecological malignancies that requires a standard of care surgical resection in the operating room
Inadequate tumor sites or volume to allow for biopsy per standard of care
Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC), either as a single agent or in combination with approved irinotecan-containing regimens
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Have standard of care biopsy or resection planned or tumors amenable to serial biopsies.
Participating would significantly delay the scheduled standard of care therapy
Scheduled for contrast CT (standard of care)
Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)
Participants whose clinical care plan includes treatment with anti-angiogenic treatment-based therapy
Is in an intensive care setting
Subject is hospitalized in the intensive care unit
Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
fMRI and/or DTI required for preoperative imaging as part of the standard of care
All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation
INCLUSION CRITERIA FOR OPEN-ACCESS: All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation
Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard care
Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care
Presently planned for ongoing octreotide according to current standard of care for at least months (i.e. throughout the study follow-up period)
Under the care of a surgical attending
Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
Known lung lesion(s) based on standard of care (SOC) non-contrast CT
Participants enrolled in other therapeutic protocols are eligible, except protocols involving a VEGF-receptor (R) inhibitor or radiation therapy outside the standard of care
Relapsed or refractory disease after a systemic standard of care treatment regimen and, if available, at least one standard of care salvage regimen
Patients on life support or in a critical care unit
Patients must have been referred for repeat tumor biopsy as part of standard care and the biopsy must have been approved by the appropriate biopsy service (interventional radiology or surgery); such approval includes review of medical history and laboratory parameters as per standard care
Planned standard of care surgery
Receiving care in the Breast Surgery Department at Columbia
Patients must be scheduled to receive a -Tesla (T) MRI exam as part of their standard of care (this exam will be\r\nmodified to also include pulse sequences which are for research only)
Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
Subjects for whom participating would significantly delay the scheduled standard of care therapy
Participation would significantly delay the scheduled standard of care therapy
Participants must be scheduled to undergo an Eovist-enhanced MRI of the liver as a part of their standard of care
Physicians determine that OCT investigation will not alter standard of care for the patient
Patient who will undergo standard of care clinical staging for UTUC
Plan to begin trabectedin as standard of care
Any major radiotherapy, or immunotherapy within the last four weeks; use of erythropoietin replacement or bisphosphonates is considered supportive care and their use is permitted
Referred from one of the above six centers, or chooses to receive care at one of the six centers
Patient is expected to see their physician or another member of their care team at least times annually
Nurse: Involved in the perioperative care of patients with breast cancer
Patients that primary care providers exclude
Patients presenting as follow-ups only at the outpatient Supportive Care Center
PATIENTS: Admitted to the Intensive Care Unit (ICU) during their hospitalization
Patients receiving care from these oncologists who are willing to complete an anonymous survey
Patients receiving care from these oncologists who are willing to be audio recorded
Patient samples will be identified from among those receiving care in one of Henry Ford Health System (HFHS) primary care clinics
All participants will be recruited from patients receiving care at the HFHS
Does not have a usual primary care provider (PCP) at baseline
Nurses covering patients on Seidman under the care of the Gynecologic Oncology service
PHASE I: Have been registered in Clinic for at least two years and assigned a primary care physician
USABILITY PHASE: Have been registered in Clinic for at least two years and assigned a primary care physician
PHASE II: Have been registered at a University of New Mexico (UNM) Clinic for six months and assigned a primary care provider
Patient of the Internal Medicine Clinic at University of North Carolina (UNC) Health Care
Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
Patients referred for consultation to the Supportive Care team
Outpatients (either new referrals or follow ups) seen in the supportive care clinic
Follow up patients seen in the outpatient Supportive Care Center
Undergoing routine oncology care and surveillance at the chosen site (defined as receiving follow-up care with FCCC or FCCCP site health care providers and have an active medical chart)
Any Grady patient who has been consented to receive chemotherapy on trial or as standard of care; there is no restriction by disease site or stage of disease
Had their cancer care primarily managed by a participating clinician
recruited through primary care sites aligned with study
Willingness to have close follow-up and treatment at the Clinic at the Seattle Cancer Care Alliance (SCCA) or at a local facility; typically, patients will be seen at least times per week as per standard practice, including at least once weekly at the SCCA