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