[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06656715":3,"trial-entities:NCT06656715":70,"trial-summary:NCT06656715":74},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":36,"std_ages":50,"locations":53,"central_contacts":63,"overall_officials":64,"references":65,"see_also_links":66},"NCT06656715","2024-1125","Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure","ACTIVE_NOT_RECRUITING","2028-09-01","2026-07","2026-07-14","2024-12-16","M.D. Anderson Cancer Center","OTHER",false,"To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).","The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).\n\nThe investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).",[18],"Heart Failure",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},102,"ACTUAL",[],[28,31],{"measure":18,"description":29,"timeFrame":30},"The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).","Through study completion, an average of 3 years",{"measure":18,"description":32,"timeFrame":30},"The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality- of-Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Measure of Quality of Life Short Form-12 (SF-12).",[],"ALL","18 Years",{"inclusion":37,"exclusion":46,"raw_text":49},[38,39,40,41,42,43,44,45],"Age 18 years and older","Individuals with a concurrent solid tumor cancer diagnosis","Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)\\[Tamoxifen\\], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists \\[Leuprolide\\], Androgen deprivation therapy for prostate cancer","Completed cancer treatment at least 3 months and up to 3 years before study enrollment.","Able to read, speak and consent in English","Ability to understand and the willingness to sign a written informed consent document","Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization","Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.",[47,48],"Participants undergoing active cancer treatment.","Inability to provide consent in the medical record, such as cognitively impaired individuals.","Inclusion Criteria:\n\n* Age 18 years and older\n* Individuals with a concurrent solid tumor cancer diagnosis\n* Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)\\[Tamoxifen\\], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists \\[Leuprolide\\], Androgen deprivation therapy for prostate cancer\n* Completed cancer treatment at least 3 months and up to 3 years before study enrollment.\n\nTherapy\n\n* Able to read, speak and consent in English\n* Ability to understand and the willingness to sign a written informed consent document\n* Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization\n* Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.\n\nExclusion Criteria:\n\n* Participants undergoing active cancer treatment.\n* Inability to provide consent in the medical record, such as cognitively impaired individuals.",[51,52],"ADULT","OLDER_ADULT",[54],{"facility":55,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"The University of Texas of MD Anderson Cancer Center","Houston","Texas","77030","United States",{"lat":61,"lon":62},29.76328,-95.36327,[],[],[],[67],{"label":68,"url":69},"MD Anderson Cancer Center","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":71,"biomarkers":73},[18,72],"Solid Neoplasm",[],{"nct_id":4,"found":14,"summary":21,"prompt_version":21}]