[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547273":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":50,"studyPopulation":40,"armGroups":51,"interventions":64,"overallOfficials":73,"centralContacts":77,"locations":82,"responsibleParty":102,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":40,"enrollmentInfo":118,"targetDuration":40,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":40,"overallStatus":85,"whyStopped":40,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":40},[9,13,16,20,23,27,30,33,37],{"measure":10,"description":11,"timeFrame":12},"Number of participants recruited","Acceptability evaluates if patients accept the intervention through the ability to recruit 60 participants in 1.5 years and a \\\u003C20% dropout rate at 9 months","at 9 months",{"measure":14,"description":15,"timeFrame":12},"Number of participants remaining in study","Acceptability evaluates if patients accept the intervention through a \\\u003C20% dropout rate at 9 months",{"measure":17,"description":18,"timeFrame":19},"Number of times navigator communicates with oncology team","Integration evaluates if the navigator can communicate with the supportive oncology and medical oncology team at least 80% of the time.","9 months",{"measure":21,"description":22,"timeFrame":19},"Number of times participants connect to resources","Integration evaluates if at least 80% of patients can connect to community and clinical resources.",{"measure":24,"description":25,"timeFrame":26},"Number of visits","Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include \\> 80% of the visits conducted.","6 months",{"measure":28,"description":29,"timeFrame":19},"Number of phone calls","Practicality evaluates if the navigator is able to deliver the intervention in person or virtual. Successful practicality benchmarks include \\>80% of follow up phone calls conducted.",{"measure":31,"description":32,"timeFrame":19},"Number of visits conducted according to the ACCESS manual","Fidelity: This is indicated if \\>80% of the visits are conducted according to the ACCESS manual.",{"measure":34,"description":35,"timeFrame":36},"Change in The Impact of Event Scale - Revised (IES-R) scores","Cancer-related distress will be measured through the Impact of Event Scale - Revised (IES-R) is a 22-item instrument to assess distress. Each item is scored 0-4, with full scale from 0-22. Higher scores indicate greater severity of symptoms related to distress.\n\nEfficacy assessed by mean differences at 9 months as compared to baseline.","Baseline and 9 months",{"measure":38,"description":39,"timeFrame":36},"Change in The Memorial Symptom Assessment Scale (MSAS)","Symptom Burden will be measured through the Memorial Symptom Assessment (MSAS) is a 32 item instrument. Each item is scored from 0 to 4 with full scale from 0-128. A higher score indicates a greater level of symptom distress.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":46,"maskingDescription":40,"whoMasked":47},"DOUBLE",[48,49],"INVESTIGATOR","OUTCOMES_ASSESSOR","Primary Objectives:\n\n1. Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer.\n2. Determine the potential impact of ACCESS on cancer related distress, symptom burden, and utilization of supportive care services.\n\nOUTLINE: Participants (N=60) are randomized to 1 of 2 groups:\n\nGROUP 1\u002FIntervention Group: Participants complete 6 individualized behavioral\u002Feducational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months.\n\nGROUP 2\u002FAttention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months.\n\n.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"ACCESS Supportive Care","EXPERIMENTAL","Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care",[57],"Behavioral: ACCESS Supportive Care",{"label":59,"type":60,"description":61,"interventionNames":62},"Attention Control","PLACEBO_COMPARATOR","Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .",[63],"Behavioral: Phone sessions",[65,69],{"type":66,"name":53,"description":67,"armGroupLabels":68,"otherNames":40},"BEHAVIORAL","ACCESS Supportive Care includes:\n\n1. Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference.\n2. Monthly check-in: Monthly check-ins (\\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks.\n3. Scheduling of outpatient supportive oncology appointment if interested.\n4. Community linkage: Warm hand offs and connection to community resources to enhance access to support groups, educational workshops, and healthy lifestyle services.",[53],{"type":66,"name":70,"description":71,"armGroupLabels":72,"otherNames":40},"Phone sessions","6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (\\~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.",[59],[74],{"name":75,"affiliation":5,"role":76},"Melissa Mazor","PRINCIPAL_INVESTIGATOR",[78],{"name":75,"role":79,"phone":80,"phoneExt":40,"email":81},"CONTACT","(510) 418-8642","melissa.mazor@mountsinai.org",[83],{"facility":84,"status":85,"city":86,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Mount Sinai Hospital","RECRUITING","New York","10029","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-74.00597,40.71427,{"lat":94,"lon":93},[97,101],{"name":98,"role":79,"phone":99,"phoneExt":40,"email":100},"Karisma Pantaleon","212-824-7986.","karisma.pantaleon2@mountsinai.org",{"name":75,"role":76,"phone":40,"phoneExt":40,"email":40},{"type":76,"investigatorFullName":75,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Assistant Professor",[105],{"name":106,"class":107},"National Cancer Institute (NCI)","NIH","100547273","enhancing-access-to-supportive-services-for-women-of-color-with-metastatic-breast-cancer-100547273",false,"NCT06405828","Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer","Project ACCESS: A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer","ACCESS","Inclusion Criteria:\n\n* Women ≥18 years of age\n* English and\u002For Spanish speaking\n* Self-identify as Latina and\u002For African American\u002FBlack\n* Ability to understand and the willingness to sign a written informed consent\n* Stage IV breast cancer diagnosis, no time component\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairment\n* receiving inpatient hospice care\n* if patients were previously enrolled in Aim 1 and Aim 2\n* currently working with a community navigator","FEMALE","18 Years",{"count":119,"type":120},67,"ESTIMATED","INTERVENTIONAL",[123],"NA","Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.",[126,127],"Metastatic Breast Cancer","Stage IV Breast Cancer AJCC V7","2026-10-08",{"date":130,"type":131},"2026-10-13","ACTUAL",{"date":133,"type":131},"2024-05-01",{"date":135,"type":120},"2027-09-01",{"name":5,"class":6},1]