[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522676":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":63,"collaborators":27,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":27,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":27,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":27,"overallStatus":47,"whyStopped":27,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychoeducational Intervention","EXPERIMENTAL","Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:",[13],"Behavioral: Psychoeducational Intervention",{"label":15,"type":10,"description":11,"interventionNames":16},"Open Label Placebo",[17],"Drug: Open Label Placebo",{"label":19,"type":10,"description":11,"interventionNames":20},"Psychoeducational Intervention+Placebo",[21],"Behavioral: Psychoeducational Intervention+Placebo",[23,28,32],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Participants in the PI group will complete the educational sessions only.",[9],null,{"type":29,"name":15,"description":30,"armGroupLabels":31,"otherNames":27},"DRUG","This group will only take placebo capsules every day.",[15],{"type":24,"name":19,"description":33,"armGroupLabels":34,"otherNames":27},"This group will take the placebo capsules every day, as well as completing the educational sessions.",[19],[36],{"name":37,"affiliation":5,"role":38},"Sriram Yennu, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":27,"email":43},"CONTACT","(713) 792-3938","syennu@mdanderson.org",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"MD Anderson Cancer Centerr","RECRUITING","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,62],{"name":37,"role":41,"phone":61,"phoneExt":27,"email":43},"713-792-3938",{"name":37,"role":38,"phone":27,"phoneExt":27,"email":27},{"type":64,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100522676","phase-2-combination-therapy-for-cancer-related-fatigue-in-patients-with-metastatic-cancers-100522676",false,"NCT06085716","Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers","Inclusion Criteria:\n\n1. Be advanced cancer patients or s or have a history of advanced cancer, having fatigue with severity of ≥ 4\u002F10, on a 0-10 scale (Edmonton Symptom Assessment Scale), and presence of fatigue for at least 2 weeks.\n2. Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13\u002F30).\n3. Be aged 18 years or older.\n4. Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.\n5. Have a hemoglobin level of ≥10 g\u002FdL within 2 weeks of enrollment.\n6. Be able to understand the description of the study and sign a written informed consent.\n7. Have a ECOG performance status score of 0 to 2; and\n8. Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)\n9. Able to read, write and speak English\n\nExclusion Criteria:\n\n1. Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician.\n2. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.\n3. Be pregnant (as documented in chart) or become pregnant while on study.","ALL","18 Years",{"count":74,"type":75},240,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.",[82,83],"Metastatic Cancers","Fatigue","2026-04-29",{"date":86,"type":87},"2026-05-05","ACTUAL",{"date":89,"type":87},"2024-02-16",{"date":91,"type":75},"2029-08-31",{"name":5,"class":6},1]