[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557035":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":91,"collaborators":94,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":25,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":25,"enrollmentInfo":112,"targetDuration":25,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acceptance and Commitment Therapy","EXPERIMENTAL","Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that the team developed to guide mindfulness practices.",[13],"Behavioral: Acceptance and Commitment Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Education\u002FSupport","ACTIVE_COMPARATOR","Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.",[19],"Behavioral: Education\u002FSupport",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Patients and caregivers in the acceptance and commitment therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients and caregivers in the education\u002Fsupport arm discuss their cancer-related concerns and receive education on services available in their medical center and community.",[15],[30],{"name":31,"affiliation":32,"role":33},"Catherine E Mosher, Ph.D.","Indiana University Indianapolis","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Hannah Mullin","CONTACT","317-278-4005","cancerq@iu.edu",[41,58,71,78],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Northwestern Medicine","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-87.65005,41.85003,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":25},"Elizabeth Addington, Ph.D.",{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Eskenazi Health","NOT_YET_RECRUITING","Indianapolis","Indiana","46202",{"type":50,"coordinates":65},[66,67],-86.15804,39.76838,{"lat":67,"lon":66},[70],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"facility":72,"status":43,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Indiana University Health",{"type":50,"coordinates":74},[66,67],{"lat":67,"lon":66},[77],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"facility":79,"status":43,"city":80,"state":81,"zip":82,"country":47,"countryCode":48,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":50,"coordinates":84},[85,86],-95.36327,29.76328,{"lat":86,"lon":85},[89],{"name":90,"role":37,"phone":25,"phoneExt":25,"email":25},"Eileen Shinn, Ph.D.",{"type":33,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Catherine Mosher","Professor of Psychology",[95,98,100,102],{"name":96,"class":97},"National Cancer Institute (NCI)","NIH",{"name":99,"class":6},"Northwestern University",{"name":101,"class":6},"M.D. Anderson Cancer Center",{"name":59,"class":6},"100557035","telephone-support-in-advanced-gastrointestinal-cancer-100557035",false,"NCT06532877","Telephone Support in Advanced Gastrointestinal Cancer","Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers","Patient Inclusion Criteria:\n\n* Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., ampullary, anal, appendix, bile duct, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving cancer care at one of the study sites.\n* Patient is at least 18 years of age.\n* Patient can speak and read English.\n* Patient has an eligible, consenting family caregiver (see criteria below).\n* Patient has moderate to severe fatigue interference with functioning.\n\nPatient Exclusion Criteria:\n\n* Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.\n* Patient reports being able to do little activity on a functional status measure.\n* Patient is receiving hospice care at screening.\n* Patient does not have working phone service.\n* Patient has hearing impairment that precludes participation.\n* Patient participated in the pilot trial testing the same intervention.\n\nCaregiver Inclusion Criteria:\n\n* Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria.\n* Caregiver has significant caregiving burden.\n* Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.\n* Caregiver is at least 18 years of age.\n* Caregiver can speak and read English.\n\nCaregiver Exclusion Criteria:\n\n* Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.\n* Caregiver does not have working phone service.\n* Caregiver has hearing impairment that precludes participation.\n* Patient declines study participation.","ALL","18 Years",{"count":113,"type":114},488,"ESTIMATED","INTERVENTIONAL",[117],"NA","The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support. The main questions it aims to answer are:\n\nDoes our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support?\n\nParticipants in both study conditions will:\n\nComplete 6 weekly telephone sessions of counseling or education\u002Fsupport Complete a telephone booster session Complete 3 telephone interviews over about 5 months",[120,121],"Gastrointestinal Neoplasm Malignant","Caregiver Burden",[123,124,9,125,126,121],"Gastrointestinal Neoplasms","Family Caregivers","Fatigue","Psychotherapy","2026-01-22",{"date":129,"type":130},"2026-01-23","ACTUAL",{"date":132,"type":130},"2024-08-21",{"date":134,"type":114},"2029-02",{"name":5,"class":6},4]