[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07690852":3,"trial-entities:NCT07690852":106,"trial-summary:NCT07690852":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":61,"sex":62,"minimum_age":63,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":80,"locations":83,"central_contacts":100,"overall_officials":101,"references":104,"see_also_links":105},"NCT07690852","260159","Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care","Precision Prevention: Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care","RECRUITING","2028-01-01","2026-08","2026-08-31","2026-12-28","City of Hope Medical Center","OTHER",true,"This study evaluates patient and provider attitudes about environmental exposure risk assessments into clinical care for female patients at average or high risk for breast cancer and\u002For diagnosed with early onset breast cancer.","PRIMARY OBJECTIVES:\n\nI. To assess patient interest and emotional responses toward EERA and return of results.\n\nII. To assess provider attitudes toward EERA integration into clinical workflows.\n\nOUTLINE: This is an observational study. Participants are assigned to 1 of 3 aims.\n\nAIM I: Average and high risk breast cancer participants and early onset breast cancer patients complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' and patients' medical records are reviewed.\n\nAIM II: COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.\n\nAIM III: Average and high risk breast cancer participants complete a baseline survey over 15-25 minutes and wear Fresh Air Clip wristbands for 1 week. Participants then complete a follow up survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' medical records are reviewed.",[19],"Breast Carcinoma",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},423,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31,"otherNames":35},"Non-Interventional Study","Non-interventional study",[32,33,34],"Observational Aim I","Observational Aim II","Observational Aim III",[36,37],"Non-Interventional Observational Study","Noninterventional (Observational) Study",[39,43,46,48,51,53,55,58],{"measure":40,"description":41,"timeFrame":42},"Patient survey responses on perceived utility","Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using analysis of covariance (ANCOVA). Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.","Up to one year",{"measure":44,"description":45,"timeFrame":42},"Patient survey responses on willingness to engage","Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using ANCOVA. Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.",{"measure":47,"description":45,"timeFrame":42},"Patient survey responses on preferences for receiving EERA results",{"measure":49,"description":50,"timeFrame":42},"Provider survey responses on perceived utility","Descriptive analysis will be used to examine all quantitative variables.",{"measure":52,"description":50,"timeFrame":42},"Provider survey responses on feasibility",{"measure":54,"description":50,"timeFrame":42},"Provider survey responses on preferences for EERA disclosures into workflows",{"measure":56,"description":57,"timeFrame":42},"Proportion of participants who wear the work wristband for a total of 1 week","Feasibility will be defined as the proportion of participants who wear the work wristband for a total of 1 week. The feasibility rate will be summarized descriptively using point estimates and 95% confidence intervals.",{"measure":59,"description":60,"timeFrame":42},"Chemical exposure measured by Fresh Air Clip wristband","Acceptability will be measured in the follow-up survey using the question: \"Overall, how acceptable did you find wearing the 'Fresh Air clip' wristband to measure chemical exposures in your daily life?\" Participants who respond \"No opinion,\" \"Acceptable,\" or \"Completely acceptable\" will be categorized as finding the wristband acceptable. The acceptability rate will be summarized descriptively using point estimates and 95% confidence intervals.",[],"FEMALE","18 Years",{"inclusion":65,"exclusion":78,"raw_text":79},[66,67,68,69,70,71,72,73,74,71,72,75,66,76,68,69,70,71,77,72,73],"ONE of the following:","Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no Pathogenic\u002FLikely Pathogenic \\[P\u002FLP\\] in breast cancer related genes) OR high risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model or gene mutation carrier, P\u002FLP carrier in breast cancer related genes including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53) OR early onset breast cancer (defined by a breast cancer diagnosis in a patient younger than 50 years of age)","Age: ≥ 18 years","Speak English or Spanish","Sex: female","Willingness to:","Participate in study activities","Permit medical record\u002F clinical laboratory result review","Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)","Provide written consent","Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no P\u002FLP in breast cancer related genes) OR High risk: empirical risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model and no P\u002FLP in breast cancer related genes) OR High Risk: gene carrier (defined by P\u002FLP carrier in breast cancer related genes, including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53)","Wear the wristband for 1 week",[],"Inclusion Criteria:\n\n* AIM 1 INCLUSION CRITERIA:\n\n  * ONE of the following:\n\n    * Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no Pathogenic\u002FLikely Pathogenic \\[P\u002FLP\\] in breast cancer related genes) OR high risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model or gene mutation carrier, P\u002FLP carrier in breast cancer related genes including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53) OR early onset breast cancer (defined by a breast cancer diagnosis in a patient younger than 50 years of age)\n  * Age: ≥ 18 years\n  * Speak English or Spanish\n  * Sex: female\n  * Willingness to:\n\n    * Participate in study activities\n    * Permit medical record\u002F clinical laboratory result review\n* AIM 2 INCLUSION CRITERIA\n\n  * Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)\n  * Willingness to:\n\n    * Participate in study activities\n* AIM 3 INCLUSION CRITERIA:\n\n  * Provide written consent\n  * ONE of the following:\n\n    * Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no P\u002FLP in breast cancer related genes) OR High risk: empirical risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model and no P\u002FLP in breast cancer related genes) OR High Risk: gene carrier (defined by P\u002FLP carrier in breast cancer related genes, including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53)\n  * Age: ≥ 18 years\n  * Speak English or Spanish\n  * Sex: female\n  * Willingness to:\n\n    * Wear the wristband for 1 week\n    * Participate in study activities\n    * Permit medical record\u002F clinical laboratory result review",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":13,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":97},"Duarte","California","91010","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Stacy W. Gray","CONTACT","626-218-4768","stagray@coh.org",{"name":91,"role":96},"PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},34.13945,-117.97729,[],[102],{"name":103,"affiliation":13,"role":96},"Stacy W Gray",[],[],{"nct_id":4,"conditions":107,"biomarkers":108},[19],[109,110,111,112,113,114,115,116,117,118,119,120,121],"ATM Gene","BARD1 Gene","BRCA1 Gene","BRCA2 Gene","CDH1 Gene","NF1 Gene","Partner and Localizer of BRCA2","PTEN Gene","RAD51C Gene","RAD51D Gene","Serine\u002FThreonine-Protein Kinase Chk2","STK11 Gene","TP53 Gene",{"nct_id":4,"found":15,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an observational study with a planned enrollment of 423 participants. It is not a treatment study but rather focuses on gathering information through surveys and interviews.","completed","Environmental Exposure Assessment in Breast Cancer Care","This observational study is looking at how patients and doctors feel about including environmental exposure risk assessments (EERA) in breast cancer care. This means understanding how environmental factors might affect breast cancer risk. The study aims to see if patients are interested in EERA, how they feel about getting these results, and what doctors think about using EERA in their practice. You may be able to join if you are a woman aged 18 or older, at average or high risk for breast cancer, or have early-onset breast cancer. The study plans to enroll 423 participants. The main goals are to understand patient and provider attitudes within one year.","Your responses will be measured for up to one year.",109,"You would complete a survey (15-25 minutes) and might have an interview (30-45 minutes). Some participants might also wear Fresh Air Clip wristbands for one week.","Not stated in the trial record.",[],"v2"]