[c09aa8]: / clusters / clusters342final / clust_162.txt

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Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC
Patient with salivary gland malignancies
Patient with thyroid cancers
In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled on AHEP0731 without a biopsy* Clinical situations in which such emergent treatment may be indicated include, but are not limited to, the following circumstances:** Anatomic or mechanical compromise of critical organ function by tumor (eg, respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc)** Uncorrectable coagulopathy* For a patient to maintain eligibility for AHEP0731 when emergent treatment is given, the following must occur:** The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alpha fetoprotein, and must meet all AHEP0731 eligibility criteria at the time of emergent treatment** Patient must be enrolled on AHEP0731 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP0731 enrollment** If the patient receives AHEP0731 chemotherapy PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims
Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible
Must be able to read, write and understand English
Parent/legal guardian and child > 7 years old able to read English or Spanish
Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits
Patients who are able to read, understand and write English; if FLIE which has been translated into other languages, and validated, becomes available, then patients speaking these languages can be enrolled if translation of the symptom diary can be arranged dependent on availability of suitable translators
Patients who are able to complete the assessments
Has a designated parent or caregiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
Patient and parent/caregiver must speak English or Spanish
Patient enrollment must occur within 4 calendar months following completion of CRT* Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT
The patient must have access to a telephone and phone number where they can be reached
The patient and caregiver must have reading, speaking and listening comprehension of English
Able to read and write in English or Spanish
STEP I: Patient enrolling to this study must agree to register to the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
STEP II: Patient enrolling to this study must agree to register to the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
Patients must have the cognitive ability to participate in the study
Patient who have undergone either a total mastectomy or a lumpectomy are eligible; (patients who have had a nipple-sparing mastectomy are eligible)
The patient must have recovered from surgery with the incision completely healed and no signs of infection
Clinical judgement by the investigator that the patient should not participate in the study
Able to hold breathe for 10 seconds
Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit; if the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll
Participant has adequate understanding of the English language
If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made
Patient must not have an antecedent hematologic disorder
United States (U.S.) patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN survey ancillary study; NOTE: Patients enrolled to S1400 prior to revision #12 are not eligible for the S1400GEN survey ancillary study; study physicians will provide participants with a hard copy of the survey (at the time of informed consent) to improve tracking and comprehension during the interview
Patient has not had prior treatment with blinatumomab
Participant is willing to be randomized and able to comply with the protocol
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
A member of the patients surgical team must indicate equipoise for the benefit of the surgical treatment for MBO; the surgeon must respond Yes to each of the following questions and sign the S1316 Surgical Equipoise Documentation form for the patient to be eligible:* Is surgery for treatment of malignant bowel obstruction (MBO) being considered for this patient?* Do you have equipoise? if the treating team finds that an operation is required (e.g., for acute abdomen), or they would not offer the patient an operation (e.g., patient is too weak to tolerate surgery), then there is no equipoise
Patients must be able to complete the study questionnaires in English or Spanish
In accordance with French Regulatory Authorities: Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees)
If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible
Must have telephone
Patient does not understand English
Ability to understand written and/or spoken English
Access to a telephone
Patients who are primary English or French speakers are eligible
The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
Patient must NOT be in liver failure as judged by the patients physician
Clinical judgment by the investigator that the patient should not participate in the study
Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)
Patient is currently pregnant; patient must agree to use two forms of birth control if they are of child-bearing potential
Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollment
Be able to read and understand English
Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record
Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines
Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires; assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult
FOR PHASE I: If patient is on erlotinib at the time of signed consent, the patient does NOT need to be discontinued prior to initiation of erlotinib and onalespib; other EGFR-TKIs must be discontinued at least 7 days prior to initiation of erlotinib and onalespib
FOR PHASE II COHORT A: If patient is on erlotinib at the time of signed consent, erlotinib does NOT need to be discontinued prior to receiving treatment erlotinib and onalespib; last dose of erlotinib must be less than 28 days from when patient signs consent
Patients who are primary English or French speakers are eligible
Able to read and comprehend either English or Spanish
Patients must speak English and have an adequate ability to view a website (primary intervention study)
Patients must be able to speak English and hear by phone
Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study
Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish
Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
Patients will be strongly encouraged to participate in 10-C-0086; if a patient does not agree to enroll on 10-C-0086, germline genetic analysis will not be performed
Clinical judgment by the investigator that the patient should not participate in the study
Patient has a doctor diagnosis of COPD
Patient is a current or ex-smoker with a smoking history of >= 10 pack years
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patient is fit to receive the randomization options for which he is being considered
If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Only English and French-speaking patients are eligible to participate
Able to fluently speak and read English
Only English or French speaking patients are eligible to participate as the cognitive assessments are only available in these languages