Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
Poorly controlled depressive symptoms, defined as a baseline score of 10 or higher on the Patient Health Questionnaire (PHQ)-9 screening tool
3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
> 0 in PHQ-9 question 9
Patients with the following mood disorders as judged by the investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM- IV]) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Meets the cut-off score of >= 12 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of \1, 2, or 3\ to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patients has any of the following mood disorders as judged by the Investigator or a Psychiatrist, or who meets the cut-off score of >= 10 on the Patient Health Questionnaire (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of ‘1, 2, or 3’ to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\nNote: The psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment
For participants on the BKM120 cohort only: \r\n* Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment will not qualify for study participation\r\n* >= CTCAE grade 3 anxiety at the time of study entry regardless of whether the anxiety is being treated with medications\r\n* Patients with the following mood disorders as judged by the investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n** Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n** >= CTCAE grade 3 anxiety\r\n** Meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patient has a score >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire
Patient selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
Patients has any of the following mood disorders as judged by the Investigator or a psychiatrist, or who meets the cut-off score of >= the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7 (GAD-7) mood scale, respectively, or selects a positive response of ‘1, 2, or 3’ to questions number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Note: the psychiatric judgment overrules the mood assessment questionnaire result or the investigators judgment
Patient has a score of >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire, selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9), score >= 15 on Generalized Anxiety Disorder (GAD)-7 mood scale
Patient has a score >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire
Patient selects a response of \1, 2 or 3\ to question number 9 on the PHQ-9-questionaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual [DSM]-IV) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety \r\n* Meets the cut-off score of >= 12 in the Patient Health Questionnaire 9-item (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patients with active moderate or severe major mood or psychiatric disorder as judged by the investigator, primary care physician, counselor, psychiatrist, or as a result of the patient‘s mood assessment questionnaire that may interfere with the ability to comply with the trial; in addition, given the prior mood-associated toxicities, patients with a history of psychiatric hospitalization within the past 5 years, electroconvulsive therapy (ECT) within the past 5 years, or whose psychiatric condition has been unstable within 2 months prior to study enrollment requiring addition or change of psychotropic medications are not eligible; examples include, but are not limited to:\r\n* Medically documented history of or active major depressive episode requiring inpatient or intensive outpatient therapy, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or active ideation, or homicidal ideation (immediate risk of doing harm to others); patients under the care of a primary care physician who are treated with one oral agent and who have not required dose adjustments or new medications within 2 months prior to study enrollment and who otherwise meet eligibility requirements may be enrolled\r\n* >= Common Terminology for Adverse Events (CTCAE) version 4.0 grade 3 anxiety\r\n* Patients meeting the cutoff score of >= 12 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder-7 (GAD-7) mood scale, respectively, or who select a positive response of \1, 2, or 3\ to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) are not eligible
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire (treating physician to decide on whether to administer questionnaire):\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4) grade 3 anxiety\r\n* Meets the cut-off score of >= 10 in the Patient Health Questionnaire 9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7 (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
For Arms A, C or D, patients with the following mood disorders as judged by the investigator or a psychiatrist, or as result of patient’s mood assessment questionnaire:\r\n* Medically documented history of major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV); NOTE: for patients with psychotropic treatments ongoing at baseline, the dose and schedule should not be modified within the previous 6 weeks prior to D1 of treatment with BKM120\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety \r\n* At screening, meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD-7) mood scale, respectively, or selects a positive response of 1, 2 or 3 to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study unless overruled by the psychiatric assessment\r\n* Note: The psychiatric judgment overrules the mood assessment questionnaire result/investigator's judgment
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Meets the cut-off score of >= 12 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Patients have any of the following mood disorders as judged by the Investigator or a Psychiatrist, or who meets the cut-off score of ? 12 the PHQ-9 or a cut-off of ? 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) see Appendix 4.
Following mood disorders as judged by the investigator and/or symptom management service co-investigator, or as a result of patient’s mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* Current >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* Meets the cut-off score of >= 10 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder 7-item (GAD-7) mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study
Patient has a score ? 12 on the PHQ-9 questionnaire.
Patient has any of the following baseline mood disorders (not attributable to GBM) as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ? 12 in the PHQ- 9 or a cut-off of ? 15 in the GAD-7 mood scale for reasons not attributable to GBM; or selects a positive response of '1, 2, 3' to question number 9 regarding potential for suicidal thoughts or ideation in the PHQ-9 (independent of the total score of the PHQ-9)
Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of patient's mood assessment questionnaire:\r\n* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n* >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety\r\n* At screening, mood rating scores of >= 10 on Patient Health Questionnaire (PHQ)-9 and/or >= 15 on Generalized Anxiety Disorder Scale (GAD)-7, unless overruled by psychiatrist's assessment\r\n* Patient selects a response of \1, 2, or 3\ for question 9 on PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)\r\n* NOTE: the psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment; if mood rating scores do not meet eligibility criteria and/or the investigator deems that a patient has mood disorder that renders the patient ineligible, that patient may not be registered to the study unless there is a subsequent psychiatric clinic consultation in which the psychiatrist overrules the mood assessment questionnaire result/investigator judgment
Patient has a score >= 12 on the Patient Health Questionnaire (PHQ)-9 questionnaire
Patient selects a response of “1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9)
Score of < 9 on the PHQ-4
No suicidal thoughts as indicated by a positive (1+) response to question 9 on the PHQ9
Score >= 10 on the Generalized Anxiety Disorder-7 Questionnaire (GAD-7) and/or a score >= 8 on the Patient Health Questionnaire-9 Item (PHQ-9), indicating clinically significant anxiety or depressive symptoms, respectively
Having a psychotic disorder or the presence of another psychiatric condition (e.g., severe depression [i.e., > 19 on the Patient Health Questionnaire-9 [PHQ-9]], suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study
Positive depression screen (PHQ-9 score >= 8) or current antidepressant treatment
A score of 25 or more on the Patient Health Questionnaire (PHQ-9) on the first visit
Severe depression (Patient Health Questionnaire [PHQ]-8 >= 20)
Suicidal ideation, as determined via Patient Health Questionnaire (PHQ)-9
Participants with major depressive disorder and/or suicidal ideation as determined by PHQ-9
Scores 20 or above on the patient health questionnaire (PHQ)-8 depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (2% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment
Currently elevated depressive symptoms; (Patient Health Questionnaire [PHQ] 2 > 2)
Meeting criteria for a current major depressive episode measured by the PHQ-9
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)
Willingness and ability to complete the EPIC questionnaire
Willingness and ability to complete the bowel and urinary domains of the EPIC prior to registration
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
Patients willing and able to complete the EPIC questionnaire in its entirety
Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire (s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete study-related (QoL, pill diary) questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) independently or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete a patient medication diary by themselves or with assistance
Ability to complete questionnaire(s), in English, by themselves or with assistance
Ability to complete medication diary by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) in English by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) alone or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete questionnaire(s) by themselves or with assistance
Ability to complete patient medication and blood pressure diaries by themselves or with assistance
Willing to complete the food frequency questionnaire (FFQ) at baseline and at 16 week visits with assistance from a dietician
Able to complete questionnaires by themselves or with assistance
Ability to complete questionnaires by themselves or with assistance
Ability to speak English and able to complete questionnaires with minimum assistance of an interpreter
The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter
Ability to comprehend English or complete questionnaires with minimal assistance of an interpreter
Phase II: Eligible patients must receive their cancer care at MGH, be able to read and write in English or able to complete questionnaires with minimal assistance required from an interpreter or family member, and also have an Eastern Cooperative Oncology Group status between 0 and 2
Ability to complete English language questionnaires by themselves or with assistance
Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member
The ability to read and respond to questions in English or with minimal help from a family member or medical interpreter
Ability to speak English or able to complete questionnaires with minimum assistance of an interpreter
PATIENT: Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member
CAREGIVER: Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member
Ability to complete questionnaires by themselves or with assistance
Ability to speak English or able to complete questionnaires with minimal assistance required from an interpreter or family member
Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter
Ability to complete the questionnaires or to do so with assistance
Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance
Ability to read questions in English or able to complete questionnaires with minimal assistance required from an interpreter or family member
Ability to read questions in English or able to complete questions with minimal assistance required from an interpreter or family member
failed to achieve a complete response after 6 or more cycles; and/or
Men who do not complete the baseline lifestyle and quality-of-life questionnaires and 3-days of diet diaries or Food Frequency Questionnaire (FFQ) (TBD) will not be eligible
Patients must be willing and able to complete all study procedures
Inability to complete baseline QOL forms
Participants with inadequate mental capacity to complete quality of life questionnaires
Able to complete all mandatory tests
Patient inability to complete baseline screening 3-day diet record
Patient must complete all required tests in section 4.
Able to complete the quality of recovery (QoR) 15 questionnaire.
Patients must be able to follow directions and complete questionnaires and exercise diaries in English
Subjects able to complete the study duration.
Willing and able to complete study procedures within the study timelines
Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
Patients must sign the treatment consent document before Turnstile II screening procedures; before the treatment starts and at each visit, the patient will be asked to complete two quality of life questionnaires; It should take about 15 minutes to complete the questionnaires (Functional Assessment of Cancer Therapy General [FACT-G], FACT-Melanoma); patients must fulfill all of the following criteria to be eligible for Turnstile II of the study
Has completed the baseline HRQOL questionnaires UNLESS is unable to complete because of literacy or limited vision
Ability to understand and complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) instruments
Inability to complete the survey instrumentation accurately
Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
Able to follow verbal and written instructions in English and complete all aspects of the study
Patients must be able to understand and provide answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)/ovarian (OV)-28 QOL questionnaires in order to participate in the trial
Patients willing and able to complete the questionnaires
Completion of patient questionnaires
Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires.
Part 2: able to complete the baseline assessment forms
Patient must complete baseline quality of life (QOL) packet
Patient willing to complete a medication diary
Willing to complete a pill diary each day
The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients who consented to QOL prior to 12/1/12 should continue to complete QOL forms per their expectation report; patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy; (The Quality of Life and Economic Substudy is available to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in English are registered to S1007 without participating in the Quality of Life and Economic Substudy\r\n* Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX screening must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Enrollment between 14 days prior to and 7 days after Step 1 Registration\r\n* Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX Recurrence Score (and it is 25 or less) will proceed to Step 2 Registration without completing the S1007 Health-Related Quality of Life Questionnaire Enrollment Form (but will complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form)
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 who are able to complete questionnaires in English, Spanish or French must participate in the quality of life assessments; (those patients who cannot complete the quality of life questionnaires in English, Spanish or French can be registered to S1404 without contributing to the quality of life studies)
Patients must complete all required pretreatment evaluations
Complete Metabolic Profile (CMP) within normal limits
Patients with pN+ or > T1 disease or who have not had a visibly complete TURBT
Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision
In the opinion of the invesgator likely to complete ? 8 weeks of treatment.
Willing and able to complete neurocognitive examination without assistance from family and companions; Note: because neurocognitive testing is one of the primary goals of this study, patients must be able to utilize English language booklets (and/or French booklets if enrolled in Canada)
Willing and able to complete quality-of-life (QOL) questionnaires by themselves or with assistance
Patients must complete appropriate pretreatment evaluation including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal
Could have been treated neoadjuvantly but have not reached pathologic complete response.
Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
Mixed (5-95%) or complete (> 95%) chimerism
Able to safely complete the six minute walk test (6MWT) as per attending physician's clinical judgement
For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French; the baseline assessment must be completed within required timelines, prior to registration/randomization; inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) or refusal to complete the questionnaires will not make the patient ineligible for the study; participation in questionnaire completion is mandatory for centers, but optional for patients
Patient must agree to complete PROs (quality of life [QoL] questionnaire) throughout the study, including after study treatment discontinuation.
Unable to complete quality of life questionnaires
Proficient in English (due to number of questionnaires not validated in other languages)
Patients must be able to complete study questionnaires in English
Patients able to complete pain assessment and quality of life surveys
Able to complete the study data collection in English
Ability to complete evaluation surveys in English
CAREGIVERS: Inability to complete study questionnaires
Patients with partial or complete limb amputations
(Caregiver participation) is willing to participate in the study and able to complete the questionnaires
Unable to complete the baseline assessment questionnaires or functional assessments
Able and willing to complete study tasks as evidenced by at least the following: fluent English speaker; hearing and language comprehension; and, sufficient literacy to complete study forms and questionnaires
Willingness and ability to complete the entire workshop, including the interviews and questionnaires (there is no predetermined qualification with regard to the ability to hold an artist tool; accommodations and creative solutions will be made to facilitate participation)
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
PATIENTS: Unable to complete baseline interview.
CAREGIVERS: Unable to complete the baseline interview.
Lymphedema Group: Ability to understand English in order to complete questionnaires
Inability to complete study forms
No Lymphedema Group: Ability to understand English in order to complete questionnaires
Can complete assessment/intervention in English
WEBSITE VISITORS: Able to complete questionnaires in English
WEBSITE VISITORS: Unable to complete questionnaires in English
Unable to complete the baseline interview
Be able to complete a steep ramp test
Men who do not complete the baseline lifestyle and quality-of-life questionnaires and food frequency questionnaire (FFQ) will not be eligible
Patient must be able to ambulate and complete the 6 minute walk test without use of a walker, cane, or any assist devices
Ability to understand and complete the study survey instruments in English
Unable to understand and complete the study survey instruments in English
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
Cognitively able to complete interviews as judged by the study team
Ability to understand English in order to complete questionnaires
Willing to complete the UNC GA
Patients must be able to complete study questionnaires in English
Agree to complete study surveys
Subjects who are unable to complete the symptom diary
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
Caregivers must be willing to complete surveys at baseline and on monthly basis
Unable to complete the baseline assessment questionnaires or functional assessments
Willing to return mail-in questionnaires during the observation phase of the study
Ability to understand English in order to complete questionnaires
Unable to complete the baseline assessment forms or to understand the recommendations for participation in the study
Cognitive impairments that would make it difficult for AYA/parents to participate in the intervention or complete questionnaires (determination in consultation with attending physician, oncologist, and, for adolescents below age 18, the parents)
Patients must be able to complete study questionnaires in English or Spanish
Patients must be able to complete questionnaires in English
Patients must be able to complete the baseline S1013 FACT EGFRI 18 within 3 days prior to initiation of EGFRI therapy
Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
Normal cognition and willingness to complete fatigue and quality of life forms at each designated time point along with a patient observation form and pill diary
Willing and able to use a computer to complete study questionnaires
Unwilling to complete online questionnaires
Ability to understand English in order to complete questionnaires
Unwilling to complete baseline and follow-up questionnaires
PHASE II: Not able to complete all study assessment and procedures in English
Able to follow verbal and written instructions in English and complete all aspects of the study.
Able to read, understand, follow the study procedure and complete crofelemer, rescue medication, and bowel movement diaries
Able to follow verbal and written instructions in English and complete all aspects of the study
Ability to complete online forms
Able to follow verbal and written instructions in English and complete all aspects of the study
Able to complete all mandatory tests
Subjects with any significant psychological disturbance that, in the opinion of the Investigator, could impair the consent process or ability to complete self-assessment questionnaires.
Able to read, understand, and complete questionnaires and diaries
Ability to complete questionnaire(s) and dietary food logs
Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI
Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life
Able to recollect dietary intake for the prior 24 hours in order to complete a one-day food record with assistance from a dietician at each study visit
Able to read adequately to complete the survey and related study documents or give consent
Patients must be able to complete the study questionnaires in English or Spanish
Participants not willing to complete interviews or survey instruments (usability test and RCT)
Complete contact information on file
Part 2 only: did not complete part 1 of the study
Ability to independently complete the study as assessed by the research staff
Individuals who are unable to complete study materials
Able and willing to complete the entire study
Able and willing to complete the entire study