[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06469307":3,"trial-entities:NCT06469307":101,"trial-summary:NCT06469307":105},{"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":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":71,"locations":74,"central_contacts":91,"overall_officials":97,"references":99,"see_also_links":100},"NCT06469307","24-177","Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)","RECRUITING","2028-01-30","2026-07","2026-07-16","2024-12-09","Dana-Farber Cancer Institute","OTHER",false,"The purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called DIVERSE.","This research study aims to pilot a protocol review process, called DIVERSE, assessing its feasibility, acceptability, and preliminary efficacy to enhance inclusion and diversity in clinical trial enrollment. Patients and community participants will complete specialized training and provide feedback on clinical trials in development through the DIVERSE process; they will also provide feedback on the process itself. Investigator participants will request review and provide feedback on the DIVERSE process. The study is based on community-based participatory research.\n\nParticipation in this research is expected to last about 18 months. It is expected that about 20 patient and community participants and 20 investigators will participate in this research study. The National Cancer Institute and American Society of Clinical Oncology are providing funding for this research study.",[18,19],"Blood Cancer","Leukemia",[18,19],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29],{"type":13,"name":30,"description":31,"armGroupLabels":32,"otherNames":35},"DIVERSE Review Process","A participant and community-based review system for clinical research protocols that elicits and collects feedback on investigator-initiated protocol reviews.",[33,34],"DIVERSE Community Advisory Board (CAB)","DIVERSE Investigators",[36],"DIVERSE",[38,42,45],{"measure":39,"description":40,"timeFrame":41},"Protocol Review Completion Rate","Feasibility is defined as the proportion of eligible protocols that have completed the DIVERSE review process. The target is a review completion of ≥ 60% of eligible protocols.","18 months",{"measure":43,"description":44,"timeFrame":41},"Protocol Review Completion Rate Within 35 Days","Feasibility is defined as the proportion of protocols that have completed the DIVERSE review process within 35 days of request. The goal is to have ≥ to 70% of reviews completed within 35 days.",{"measure":46,"description":47,"timeFrame":41},"Proportion of Acceptability of Intervention Measure (AIM) Scores of 10 or Greater","Acceptability is defined as the proportion of AIM scores provided by investigators after protocols have been assessed by the DIVERSE review process with ≥ 60% of AIM scores resulting as ≥10 on a scale of 0 - 20, where scores of 10 or above are considered \"acceptable\" or greater. The AIM is a 4-item, 5-point Likert scale-based measure.",[],"ALL","18 Years",null,true,{"inclusion":54,"exclusion":63,"raw_text":70},[55,56,57,58,59,60,61,62],"Age 18 or older","English speaking","Ability to understand and willingness to provide oral consent","DFCI patient who are in remission from a blood cancer \\>1 year will be preferred.","Age 18 older","English Speaking","Site or Principal investigator","Not a member of the research team",[64,65,66,67,68,69],"Adults unable to consent","Individuals who are not yet adults (infants, children, teenagers \\\u003C18 years old)","Prisoners.","Unwilling\u002Funable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in Section 9.1","Note 1: Patients and non-patient community members who are pregnant are eligible. This is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. Pregnancy status will not be assessed.","Note 2: English fluency is necessary as protocols being reviewed are written in English and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews.","CAB Participant Inclusion Criteria:\n\n* Age 18 or older\n* English speaking\n* Ability to understand and willingness to provide oral consent\n* DFCI patient who are in remission from a blood cancer \\>1 year will be preferred.\n\nCAB Participant Exclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C18 years old)\n* Prisoners.\n* Unwilling\u002Funable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in Section 9.1\n* Note 1: Patients and non-patient community members who are pregnant are eligible. This is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. Pregnancy status will not be assessed.\n* Note 2: English fluency is necessary as protocols being reviewed are written in English and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews.\n\nInvestigator Participant Inclusion Criteria:\n\n* Age 18 older\n* English Speaking\n* Site or Principal investigator\n* Not a member of the research team",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":12,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":88},"Boston","Massachusetts","02215","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Andrew Hantel, MD","CONTACT","617-582-9394","Andrew_Hantel@dfci.harvard.edu",{"name":82,"role":87},"PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},42.35843,-71.05977,[92,93],{"name":82,"role":83,"phone":84,"email":85},{"name":94,"role":83,"phone":95,"email":96},"Oldy S Bejarano, MPH","857-215-2365","oldy_bejarano@dfci.harvard.edu",[98],{"name":82,"affiliation":12,"role":87},[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[19,103],"Liquid Tumor",[],{"nct_id":4,"found":52,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an interventional study with a planned enrollment of 40 participants. It involves a community-based review system for clinical research protocols.","completed","DIVERSE Study: Improving Clinical Trial Inclusion for Blood Cancer","This study, called DIVERSE, aims to make clinical trials more inclusive and diverse. It tests a new system where patients and community members review and give feedback on research plans for future clinical trials. You could join if you are 18 or older, speak English, and can give consent. People who have been in remission from blood cancer for over a year are preferred. The study will be successful if many reviews are completed, especially within 35 days, and if participants find the DIVERSE process acceptable. The current recruitment status is unclear.","The primary goals of the study are measured at 18 months, indicating the duration of observation for the intervention's effectiveness.",92,"Participation in this research is expected to last about 18 months. You would complete specialized training and provide feedback on clinical trials and the DIVERSE process itself.","Not stated in the trial record.",[],"v2"]