[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06559228":3,"trial-entities:NCT06559228":89,"trial-summary:NCT06559228":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":37,"secondary_outcomes":45,"sex":58,"minimum_age":59,"maximum_age":14,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":70,"locations":73,"central_contacts":82,"overall_officials":83,"references":87,"see_also_links":88},"NCT06559228","2024LS102","ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care","ACTIVE_NOT_RECRUITING","2026-08-31","2026-08","2026-08-18","2025-06-12","University of Minnesota","OTHER",null,"Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. With new advancements in treatment and rising out-of-pocket expenses, individuals facing cancer are especially vulnerable to the adverse effects of SDoH. To address these barriers, a novel solution is needed to support oncology patients, clinical teams, and community-based organizations (CBOs) across the cancer continuum. In a Phase I contract award, XanthosHealth developed ConnectedNest, a novel electronic social care referral platform to screen for SDoH needs and connect individuals with cancer to social and community services provided by CBOs while engaging the oncology team in the SDoH referral process. Through additional funding, a pilot study was completed in Minneapolis, Minnesota, in partnership with Minnesota Cancer Alliance, involving the collaboration of 14 CBOs focused on cancer. 50 cancer survivors from these CBOs were enrolled to utilize the ConnectedNest platform for a 90-day duration. Our study involved the collection and analysis of crucial metrics related to patient and CBO engagement, SDoH needs, and the volume of feasible social care referrals. In Phase II, the technical features and integration capabilities of ConnectedNest will be enhanced based on learnings in Phase I and completed pilot study. The platform will be implemented and tested among patients seen at multiple oncology clinics, evaluating health outcomes of patients who use the platform.",[17],"Cancer",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[22],"PHASE2",{"count":24,"type":25},400,"ACTUAL",[27,32],{"type":13,"name":28,"description":29,"armGroupLabels":30},"ConnectedNest","Participants will receive a secure message to register and download ConnectedNest's patient app, EmpowerNest. They will be asked to complete a set of modules at baseline through ConnectedNest to understand their health related social needs and programs available to meet those needs. They will receive basic training on the functionality and services available within the app and asked to use the app to identify and connect with needed social and community services for 90 days. Participants will be directed to complete a survey at baseline, 30, 60, and 90 days to collect patient-reported outcomes.",[31],"ConnectedNest adults",{"type":13,"name":33,"description":34,"armGroupLabels":35},"Standard of care","Participants will be directed to complete a survey at baseline, 30, 60 and 90 days to collect patient-reported demographics, cancer characteristics and outcomes metrics",[36],"Standard of care adults",[38,42],{"measure":39,"description":40,"timeFrame":41},"Change in Number of Self-Reported Social Needs","change in the number of reported social needs from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool.","Day 90",{"measure":43,"description":44,"timeFrame":41},"Change in Number of Reported Social Needs That Are Partially or Completely Met","change in the number of reported social needs that are partially or completely met from baseline (time of randomization) to day 90 after enrollment using the validated Accountable Health Communities Health-related social needs screening tool.",[46,49,52,55],{"measure":47,"description":48,"timeFrame":41},"Change in Number of Connections With Social and Community Services","Change in the number of reported connections with social and community services from baseline (time of randomization) to day 90 after enrollment",{"measure":50,"description":51,"timeFrame":41},"Change in Distress as Assessed by the NCCN Distress Thermometer","Change in self-reported levels of distress using the National Comprehensive Cancer Network (NCCN) distress thermometer from baseline (time of randomization) to day 90 after enrollment",{"measure":53,"description":54,"timeFrame":41},"Change in Satisfaction With Care as Assessed by the Patient Satisfaction Questionnaire","Change in self-reported satisfaction with care from baseline (time of randomization) to day 90 after enrollment using the Patient Satisfaction Questionnaire",{"measure":56,"description":57,"timeFrame":41},"Change in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General","Change in self-reported quality of life from baseline (time of randomization) to day 90 after enrollment using the Functional Assessment of Cancer Survey-General","ALL","18 Years",false,{"inclusion":62,"exclusion":67,"raw_text":69},[63,64,65,66],"Adults, age 18 and over","undergoing active cancer therapy or in survivorship","must be able to read and write in English","Seen in a participating Minnesota oncology clinic",[68],"Children","Inclusion Criteria:\n\n* Adults, age 18 and over\n* undergoing active cancer therapy or in survivorship\n* must be able to read and write in English\n* Seen in a participating Minnesota oncology clinic\n\nExclusion Criteria:\n\n* Children",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":12,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Minneapolis","Minnesota","55455","United States",{"lat":80,"lon":81},44.97997,-93.26384,[],[84],{"name":85,"affiliation":12,"role":86},"Helen Parsons, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Malignant Neoplasm",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This study is an interventional study planning to enroll 400 participants. It compares using the ConnectedNest digital platform to standard care.","completed","ConnectedNest: Digital Platform for Cancer Social Care","This study is testing a digital platform called ConnectedNest, which includes a patient app called EmpowerNest. The goal is to help people with cancer address social needs like housing or food insecurity, which can affect their health. You would either use the ConnectedNest app to identify and find resources for your social needs, or complete surveys about your social needs and health. Researchers want to see how many social needs are reported and how many are met after 90 days. This study is for adults aged 18 and older who are currently receiving cancer treatment or are in survivorship, can read and write English, and are seen at a participating Minnesota oncology clinic. The study is planning to enroll 400 participants, but its current recruitment status is unclear.","Participants will be followed for 90 days after baseline to measure social needs and how many are met.",128,"You would either use the ConnectedNest app and complete modules, or complete surveys at baseline, 30, 60, and 90 days.","Not stated in the trial record.",[28],"v2"]