[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07434817":3,"trial-entities:NCT07434817":136,"trial-summary:NCT07434817":140},{"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":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":50,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":125,"overall_officials":131,"references":134,"see_also_links":135},"NCT07434817","25-2154.cc","Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment","Improving Breast Cancer Patients' Self-Efficacy and Sexual Health Quality of Life","NOT_YET_RECRUITING","2028-01","2026-02","2026-02-27","2027-01","University of Colorado, Denver","OTHER",true,"Approximately 200 English- or Spanish-speaking women newly diagnosed with stage I-III breast cancer will be randomized to either receive access to an online sexual health video series or receive usual care. Participants will complete surveys at baseline and every two months for six months, measuring self-efficacy in patient-provider communication and perceived barriers to discussing sexual health. Electronic health record review will assess utilization of sexual-health-related medical and supportive services. A subset of participants will participate in qualitative interviews to explore their sexual health experiences during treatment and, for those receiving the intervention, the perceived impact of the videos.",null,[19,20],"Breast Cancer Females","Newly Diagnosed Breast Cancer",[22],"English and Spanish Speaking","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},200,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Sexual Health Educational Video Series","Participants randomized to the intervention arm will receive multiprong access to the videos, including a link provided through email and the recruitment sites' patients portal, a QR code, and tablets available in each clinic.",[36],"Intervention Arm",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Standard Care (in control arm)","Standard Care",[41],"Control Arm",[43,47],{"measure":44,"description":45,"timeFrame":46},"Participant self-efficacy discussing sexual health with breast cancer providers","Changes in participant self-efficacy to discuss sexual health with breast cancer providers will be assessed using the Perceived Efficacy in Patient-Physician Interactions (PEPPI-5), administered at enrollment and every two months over a six-month period. The PEPPI-5 is a 5-item measure scored on a 5-point Likert scale, with higher scores indicating greater perceived self-efficacy in communicating with healthcare providers.","Baseline, 2 months, 4 months, 6 months",{"measure":48,"description":49,"timeFrame":46},"Perceived barriers to discussing sexual health with breast cancer providers","Measured using the 13-item Barriers to Sexual Health Communication (BSHC) scale. Items are rated on a 5-point Likert scale; higher scores reflect greater perceived communication barriers.",[51,55],{"measure":52,"description":53,"timeFrame":54},"Use of medical and supportive services outside of treatment-plan related visits","Participant use of medical and supportive services outside of treatment-plan-related visits will be assessed through electronic health record review from enrollment through 12 months of follow-up. Services of interest will include supportive care, behavioral health, sexual health, rehabilitation, and other ancillary services. Self-reported data collected at enrollment will capture utilization of relevant medical and supportive services in the period prior to study participation.","12 months",{"measure":56,"description":57,"timeFrame":58},"Qualitative measure: Patient-reported experiences with sexual health and perceived impact of the video content.","Patient sexual health will be assessed qualitatively through semi-structured interviews with a subset of participants at six months following breast cancer diagnosis. Interviews will explore participants' experiences with sexual health concerns and evaluate how the video content did or did not influence their knowledge, communication, coping, and perceived support related to sexual health during treatment and survivorship.","One time, 60 minute interview, 6-12 months after enrollment","FEMALE","18 Years",false,{"inclusion":63,"exclusion":70,"raw_text":76},[64,65,66,67,68,69],"Provision to sign and date the consent form.","Stated willingness to comply with all study procedures and be available for the duration of the study.","Age minimum 18","Be a female as assigned on birth certificate","Ability to read and speak English or Spanish","A recent diagnosis of Stage 1-III invasive breast cancer and receiving treatment for breast cancer at the University of Colorado or Denver Health breast center(s).",[71,72,73,74,75],"Age less than 18 years old","Stage 0 or Stage IV breast cancer","Prior breast cancer diagnosis","Non-breast cancer diagnoses","Prior exposure to anti-hormone therapy, chemotherapy, or radiotherapy not related to breast cancer","Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Age minimum 18\n* Be a female as assigned on birth certificate\n* Ability to read and speak English or Spanish\n* A recent diagnosis of Stage 1-III invasive breast cancer and receiving treatment for breast cancer at the University of Colorado or Denver Health breast center(s).\n\nExclusion Criteria:\n\n* Age less than 18 years old\n* Stage 0 or Stage IV breast cancer\n* Prior breast cancer diagnosis\n* Non-breast cancer diagnoses\n* Prior exposure to anti-hormone therapy, chemotherapy, or radiotherapy not related to breast cancer",[78,79],"ADULT","OLDER_ADULT",[81,98,108,115],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":95},"University of Colorado Hospital","Aurora","Colorado","80045","United States",[88,92],{"name":89,"role":90,"email":91},"Sarah Leslie, MPH","CONTACT","Sarah.Leslie@cuanschutz.edu",{"name":93,"role":94},"Sarah Tevis, MD","PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},39.72943,-104.83192,{"facility":99,"city":100,"state":84,"zip":101,"country":86,"contacts":102,"geoPoint":105},"Denver Health Hospital and Clinic","Denver","80204",[103,104],{"name":89,"role":90,"email":91},{"name":93,"role":94},{"lat":106,"lon":107},39.73915,-104.9847,{"facility":109,"city":100,"state":84,"zip":110,"country":86,"contacts":111,"geoPoint":114},"UCHealth Cherry Creek Medical Center","80206",[112,113],{"name":89,"role":90,"email":91},{"name":93,"role":94},{"lat":106,"lon":107},{"facility":116,"city":117,"state":84,"zip":118,"country":86,"contacts":119,"geoPoint":122},"UCHealth Highlands Ranch Hospital","Highlands Ranch","80129",[120,121],{"name":89,"role":90,"email":91},{"name":93,"role":94},{"lat":123,"lon":124},39.55388,-104.96943,[126,128],{"name":89,"role":90,"phone":127,"email":91},"303-724-8995",{"name":93,"role":90,"phone":129,"email":130},"303-724-2750","sarah.tevis@cuanschutz.edu",[132],{"name":133,"affiliation":13,"role":94},"Sarah Tevis",[],[],{"nct_id":4,"conditions":137,"biomarkers":139},[138],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This study will randomly assign about 200 participants to either receive access to an online sexual health video series or receive standard care.","completed","Educational Video Series for Women in Breast Cancer Treatment","This study is looking at whether an educational video series can help women with newly diagnosed breast cancer feel more confident talking about sexual health with their doctors. It also wants to see if the videos can help reduce things that make it hard to have these conversations. About 200 women will either get access to these videos or receive their usual care. You would need to be at least 18 years old, a female assigned at birth, and able to read English or Spanish. You also need a recent diagnosis of Stage 1-III invasive breast cancer and be currently receiving treatment. The study is currently unclear on its recruitment status.","Participants will be followed for six months, with surveys completed at baseline, 2 months, 4 months, and 6 months.",111,"You would complete surveys at the beginning of the study and then every two months for six months. Some participants will also be asked to do interviews.","Not stated in the trial record.",[],"v2"]