[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04674267":3,"trial-entities:NCT04674267":94,"trial-summary:NCT04674267":108},{"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":25,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":69,"locations":71,"central_contacts":88,"overall_officials":90,"references":92,"see_also_links":93},"NCT04674267","20-275","Resilience and Equity in Aging, Cancer, and Health (REACH)","Resilience and Equity in Aging, Cancer, and Health (REACH): Promoting Physical Resilience and Cancer Care Equity for Adults Age 70 and Older Diagnosed With Gastrointestinal Malignancy","RECRUITING","2026-12-31","2026-03","2026-03-18","2022-01-18","Dana-Farber Cancer Institute","OTHER",true,"The purpose of this multi-phase research study is to understand how consultation of cancer care with a geriatrician can best improve outcomes for older adults with gastrointestinal malignancies.","This research study will be conducted in three phases:\n\n* Phase 1 - Needs assessment and implementation plan\n* Phase 2 - Pilot Intervention\n* Phase 3 - Expanded Clinical Trial\n\n  * Please note Phase 2 - Pilot Intervention and Phase 3 - Expanded Clinical Trial will be added to the clinicaltrials.gov record once Institutional Review Board (IRB) approved.\n\nPhase 1 is composed of three aims and will inform the subsequent two phases:.\n\n* Aim 1: To evaluate the perceived needs of Older Adults diagnosed with gastrointestinal malignancies, caregivers, staff, and faculty to characterize the implementation setting for a geriatric consultation.\n* Aim 2: To refine the proposed REACH program implementation plan based on qualitative feedback provided by Older Adult (OA) patients, their identified caregivers, staff, and faculty.\n* Aim 3: Determine the patient, demographic, social determinants, clinical and disease characteristics of Older Adults (OA) associated with ED visits\u002Fhospitalization following initial oncology consultation at DF\u002FBWCC in year 2019.\n* Phase 2 intervention has started as of January 2022 following IRB approval. Study team has begun recruiting participants into Phase 2 intervention of REACH study starting in January 2022. Participants approached by REACH coordinator for consenting and enrollment after their initial consult visit at Dana-Farber\u002FBrigham and Women's Cancer Center (DF\u002FBWCC). Participants are then asked to complete an electronic fitness assessment (EFA) that is sent to them via Patient Gateway. Participants complete this questionnaire and receive a score of \"Robust\", \"Pre-frail\", or \"Frail\" - those who score \"Pre-frail\" or \"Frail\" will be randomized to meet with a study geriatrician for geriatric co-management intervention alongside their standard oncology care. All enrolled participants will be followed for a duration of 1 year as they are continuing care at DF\u002FBWCC.",[19,20,21,22,23,24],"Gastric Cancer","Colon Cancer","Esophageal Cancer","Rectal Cancer","Pancreatic Cancer","Gastrointestinal Cancer",[26],"Gastrointestinal cancer","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[30],"NA",{"count":32,"type":33},257,"ESTIMATED",[35],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Phase 2 Intervention - Geriatric Co-Management","Participants will complete an electronic fitness assessment questionnaire - once completed, they will receive a score of \"Robust\", \"Pre-Frail\" or \"Frail\". Those who are \"Pre-frail\" or \"Frail\" will be randomized to meet with a study geriatrician for geriatric co-management in addition to usual oncology care. All participants will be followed for a duration of 1 year.",[39],"Intervention Phase - Geriatric Co-Management",[41,45,48],{"measure":42,"description":43,"timeFrame":44},"Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)","EFA questionnaire deployed to older adult patients age 70+ in the REACH study. Feasibility will be determined by the proportion of participants who consent to complete the electronic fitness assessment. The intervention will be considered feasible if 70% of participants consent to complete the fitness assessment.","1 year",{"measure":46,"description":47,"timeFrame":44},"Acceptability of electronic fitness assessment questionnaire","Acceptability of electronic fitness assessment questionnaire via the Patient Portal or internet-enabled device following second clinic visit among older adults diagnosed with gastrointestinal cancer seeking consultation at DF\u002FBWCC for medical, radiation, or surgical oncology. Acceptability will be determined by the proportion of participants who fully complete the EFA. The intervention will be considered acceptable if 60% of enrolled participants fully complete the EFA within 14 days of enrollment.",{"measure":49,"description":50,"timeFrame":44},"Association of geriatric consultation with number of unplanned ED visits\u002Fhospitalizations among older adult participants","Association of geriatrician consult with number of ED visits\u002Fhospitalizations among older adults diagnosed with gastrointestinal cancer randomized to the geriatric consultation intervention. Randomization will be essential to evaluate the efficacy of geriatric consultation intervention in impacting unplanned ED visits and hospitalizations.",[],"ALL","70 Years",null,false,{"inclusion":57,"exclusion":62,"raw_text":68},[58,59,60,61],"Patients who are age 70+ at time of initial consult at DF\u002FBWCC","Diagnosed with a gastrointestinal cancer, including: cancers of the esophagus, stomach, pancreas, liver, bile duct, ampulla, colon, rectum, or anus, as well as neuroendocrine tumors.","Continuing care at DF\u002FBWCC beyond initial consult visit","English and Spanish-speaking",[63,64,65,66,67],"Patients less than age 70 at time of initial consultation appointment with DF\u002FBWCC.","Patients who are not continuing care at DF\u002FBWCC beyond first consult visit.","Not proficient in English or Spanish","Patient who are not considered appropriate for enrollment due to complex medical, social, or other situation as determined by their primary oncology team.","Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","Inclusion Criteria:\n\n* Patients who are age 70+ at time of initial consult at DF\u002FBWCC\n* Diagnosed with a gastrointestinal cancer, including: cancers of the esophagus, stomach, pancreas, liver, bile duct, ampulla, colon, rectum, or anus, as well as neuroendocrine tumors.\n* Continuing care at DF\u002FBWCC beyond initial consult visit\n* English and Spanish-speaking\n\nExclusion Criteria:\n\n* Patients less than age 70 at time of initial consultation appointment with DF\u002FBWCC.\n* Patients who are not continuing care at DF\u002FBWCC beyond first consult visit.\n* Not proficient in English or Spanish\n* Patient who are not considered appropriate for enrollment due to complex medical, social, or other situation as determined by their primary oncology team.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",[70],"OLDER_ADULT",[72],{"facility":13,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":85},"Boston","Massachusetts","02215","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Nadine J McCleary, MD, MPH","CONTACT","877-442-3324","NJ_McCleary@dfci.harvard.edu",{"name":79,"role":84},"PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},42.35843,-71.05977,[89],{"name":79,"role":80,"phone":81,"email":82},[91],{"name":79,"affiliation":13,"role":84},[],[],{"nct_id":4,"conditions":95,"biomarkers":107},[96,97,98,99,100,101,102,103,104,105,106],"Ampullary Cancer","Anal Carcinoma","Bile Duct Carcinoma","Colon Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Liver Carcinoma","Malignant Digestive System Neoplasm","Neuroendocrine Neoplasm","Pancreatic Carcinoma","Rectal Carcinoma",[],{"nct_id":4,"found":15,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study with a planned enrollment of 257 participants. It involves a Phase 2 intervention where some participants will be randomized to receive geriatric co-management.","completed","REACH Study: Geriatric Co-Management for Older Adults with GI Cancers","This study, called REACH, is looking at how involving a geriatrician (a doctor specializing in older adults' health) in the care of older adults with gastrointestinal (GI) cancers might improve their health. You could be eligible if you are 70 or older, have a GI cancer (like stomach, colon, or pancreatic cancer), and receive care at DF\u002FBWCC. The study is testing a \"Geriatric Co-Management\" approach. Participants will complete a questionnaire to assess their fitness. If you are identified as \"Pre-Frail\" or \"Frail,\" you might be randomized to meet with a geriatrician in addition to your usual care. The researchers want to see if this consultation can reduce unplanned emergency room visits or hospital stays. The study is currently recruiting for its Phase 2 intervention.","The study will measure outcomes like unplanned ED visits and hospitalizations for one year.",124,"Participants will complete an electronic fitness assessment questionnaire. Those identified as \"Pre-Frail\" or \"Frail\" may be randomized to meet with a study geriatrician.","Not stated in the trial record.",[],"v2"]