[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07482384":3,"trial-entities:NCT07482384":112,"trial-summary:NCT07482384":116},{"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":24,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":46,"secondary_outcomes":51,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":83,"locations":85,"central_contacts":104,"overall_officials":107,"references":110,"see_also_links":111},"NCT07482384","25-771","Supporting Health Including Endocrine Treatment for Long Duration","Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention","RECRUITING","2027-05","2026-08","2026-08-10","2026-08-04","Dana-Farber Cancer Institute","OTHER",false,"This research is being done to pilot an intervention which aims to test a new web- and mobile application (\"app\")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.","This research study is a single-arm intervention pilot study to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease prescribed long-term endocrine treatment. The SHIELD portal is designed to help monitor the frequency and variation in cancer and treatment-related issues and to share self-management information and resources to those interested in particular issues or who indicate a specific concern, symptom or side effect on measures designed to assess and track salient symptoms.\n\nResearch study procedures include screening for eligibility, in-clinic and virtual approaches for recruitment, gaining access and using the SHIELD web- and mobile app-based supportive care portal, and completing of survey assessments on the SHIELD portal.\n\nParticipation in this research study is expected to last 3 months.\n\nIt is expected that 30 people will take part in this research study.",[19,20,21,22,23],"Breast Cancer","Breast Cancer - Female","Breast Carcinoma","ER Positive Breast Cancer","PR-Positive Breast Cancer",[25,26,27,28,29],"Breast cancer","Breast cancer female","Breast carcinoma","ER+","SHIELD","INTERVENTIONAL","SUPPORTIVE_CARE",[33],"NA",{"count":35,"type":36},30,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":44},"BEHAVIORAL","SHIELD portal","All participants will receive access to the SHIELD portal. The portal includes educational modules, symptom and side effect tracking, tailored informational resources, and health behavior tools. Participants can access the portal via smartphone, tablet, or computer. The portal is HIPAA compliant and HITRUST certified.",[43],"SHIELD Portal Interventional",[45],"Supporting Health Including Endocrine Treatment for Long Duration (SHIELD) Portal",[47],{"measure":48,"description":49,"timeFrame":50},"Enrollment Yield","Enrollment yield is defined as the proportion of participants approached for the study intervention (SHIELD, Supporting Health Including Endocrine Treatment for Long Duration) who enroll.","up to 3 weeks",[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Assessment Completion Rate","Assessment completion rate is defined as the proportion of assessments completed to assessments offered.","Up to 3 months",{"measure":57,"description":58,"timeFrame":55},"Patient Information Resources Access Rate","Patient information resources access rate is defined as the proportion of patient information resources accessed to the total number delivered.",{"measure":60,"description":61,"timeFrame":55},"SHIELD Portal Access","The number of times the SHIELD portal is accessed per month.","FEMALE","18 Years","49 Years",{"inclusion":66,"exclusion":76,"raw_text":82},[67,68,69,70,71,72,73,74,75],"Female","Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer","Premenopausal","In active treatment (including long-term endocrine therapy) at the time of enrollment","Able to speak, understand and read English","Access to a US-based mobile phone number","Cognitively able to complete study requirements","Ability to access medical records from treating hospital (DFCI)","Willing to provide cell phone number and\u002For email address and willing to receive email, mobile push notifications, and\u002For text messages from the study team",[77,78,79,80,81],"Individuals under age 18 or over age 50 at initial breast cancer diagnosis","Stage IV or metastatic breast cancer","Pregnant patients","Individuals who do not have a US mobile phone number","Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.","Inclusion criteria\n\nParticipants will be eligible if they meet the following eligibility criteria:\n\n* Female\n* Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer\n* Premenopausal\n* In active treatment (including long-term endocrine therapy) at the time of enrollment\n* Able to speak, understand and read English\n* Access to a US-based mobile phone number\n* Cognitively able to complete study requirements\n* Ability to access medical records from treating hospital (DFCI)\n* Willing to provide cell phone number and\u002For email address and willing to receive email, mobile push notifications, and\u002For text messages from the study team\n\nExclusion criteria\n\nParticipants will be ineligible if they meet any of the following criteria:\n\n* Individuals under age 18 or over age 50 at initial breast cancer diagnosis\n* Stage IV or metastatic breast cancer\n* Pregnant patients\n* Individuals who do not have a US mobile phone number\n* Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.",[84],"ADULT",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":101},"Boston","Massachusetts","02215","United States",[92,97],{"name":93,"role":94,"phone":95,"email":96},"Ann H Partridge, MD, MPH","CONTACT","617-632-6800","ann_partridge@dfci.harvard.edu",{"name":98,"role":94,"phone":99,"email":100},"Kate Dibble, Ph.D.","617-582-8294","katee_dibble@dfci.harvard.edu",{"lat":102,"lon":103},42.35843,-71.05977,[105,106],{"name":93,"role":94,"phone":95,"email":96},{"name":98,"role":94,"phone":99,"email":100},[108],{"name":93,"affiliation":13,"role":109},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":114},[21],[115],"HR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR",{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is a single-arm pilot study, meaning all 30 participants will receive access to the SHIELD portal. There is no comparison group. The study aims to assess the feasibility of enrolling participants.","completed","SHIELD Portal for ER\u002FPR-Positive Breast Cancer","This study is testing a new web and mobile app called the SHIELD portal. The portal offers educational materials, symptom tracking, and health tools to support women with hormone receptor-positive (ER\u002FPR-positive) breast cancer who are receiving long-term endocrine therapy. We want to see how well we can enroll participants and how useful the SHIELD portal is. You might be able to join if you are a woman between 18 and 49 years old, diagnosed with stage 0-IIIa HR+ breast cancer, premenopausal, currently undergoing treatment, and can speak and read English. The main goal is to see how many people enroll in the study within three weeks.","The primary endpoint, Enrollment Yield, is measured at up to 3 weeks. The study duration is 3 months, but specific follow-up after this period is not detailed.",106,"You would be screened for eligibility, then access and use the SHIELD web and mobile app. You would also complete survey assessments on the portal. Participation is expected to last 3 months.","Not stated in the trial record.",[40],"v2"]