[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03245411":3,"trial-entities:NCT03245411":115,"trial-summary:NCT03245411":133},{"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":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":82,"locations":85,"central_contacts":104,"overall_officials":110,"references":113,"see_also_links":114},"NCT03245411","4950","Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients","A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community","RECRUITING","2026-12-31","2026-05","2026-05-29","2017-07-20","Thomas Jefferson University","OTHER",true,"Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The majority of patients have a diverse cultural background, low literacy, and poor social-economic status. Medication adherence for chronic medical problems is in a range of 40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in detail. The main objective is to study medication adherence to oral anticancer agents in patients with low literacy and poor socio-economic status.","Until recently, contemporary approaches to cancer care have failed to consistently tailor communication approaches to patients with low health literacy. They have produced mixed results in regard to implementation of successful interventions in addressing the needs of this populations. Low health literacy is especially common in medically underserved communities, including in North Philadelphia. Cancer treatment, including cancer chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere to care and achieve the goals of therapy. Patients with low health literacy find it especially challenging to navigate cancer treatment. Results of previous research showed that intervention strategies that address the needs for information and material support of African American older adults, can help improve adherence to cancer screening in this population.\n\nThe purpose is to develop and evaluate model interventions to improve healthcare outcomes for socially disadvantaged populations. The objective in this proposal is to conduct a randomized controlled trial that evaluates the effects of an intervention that provides enhanced education and material support, on adherence to care, among the cancer patients of the Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.\n\nThe central hypothesis is that compared to the standard educational intervention delivered by a registered nurse, the addition of an enhanced intervention (enhanced education, problem-solving skills and facilitative support) will result in greater adherence care, especially among patients with low health literacy.",[19],"Cancer",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},110,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Intervention","All participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated.",[33],"Intervention Group",[35],{"measure":36,"description":37,"timeFrame":38},"Adherence to oral chemotherapy","Frequency of missed chemotherapy doses post randomization (based on interviews)","6 months",[40,43,46],{"measure":41,"description":42,"timeFrame":38},"Frequency of medication refills","Prescription refills, based on pharmacy records",{"measure":44,"description":45,"timeFrame":38},"Adherence to scheduled follow-up medical care visits","Frequency and adherence to schedule follow up visit",{"measure":47,"description":48,"timeFrame":38},"Healthcare utilization","Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)","ALL","18 Years",null,false,{"inclusion":54,"exclusion":72,"raw_text":81},[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"All patients on oral chemotherapeutic agents","Clinical diagnosis of stage IV breast cancer","Clinical diagnosis of stage III and IV colorectal cancer (not receiving concurrent radiation therapy)","Clinical diagnosis of stage IV non-small cell lung cancer","Clinical diagnosis of stage IV renal cell carcinoma","Clinical diagnosis of stage IV ovarian carcinoma","Clinical diagnosis of multiple myeloma","Clinical diagnosis of chronic myelogenous leukemia on TKI","Clinical diagnosis of myelodysplastic syndrome on Lenalidomide","Adjuvant treatment for Gastro Intestinal Stromal Tumor","Clinical diagnosis of chronic Lymphocytic Leukemia","Clinical diagnosis of metastatic Prostate cancer","Clinical diagnosis of hepatocellular Carcinoma","Clinical diagnosis of stage IV Melanoma","Clinical diagnosis of myelofibrosis\u002Fmyeloproliferative neoplasms","Age \\>18 years","ECOG Performance Status \\\u003C3",[73,74,75,76,77,78,79,80],"ECOG Performance Status of 3 and above","Concurrent chemo radiation","Non-English speaker","Clinical diagnosis of dementia, or otherwise unable to give informed consent.","History of non-compliance (defined as the history of 2 or more missed appointments in the clinic).","Pregnant patients","Nursing Home Patients","Incarcerated","Inclusion Criteria:\n\n* All patients on oral chemotherapeutic agents\n* Clinical diagnosis of stage IV breast cancer\n* Clinical diagnosis of stage III and IV colorectal cancer (not receiving concurrent radiation therapy)\n* Clinical diagnosis of stage IV non-small cell lung cancer\n* Clinical diagnosis of stage IV renal cell carcinoma\n* Clinical diagnosis of stage IV ovarian carcinoma\n* Clinical diagnosis of multiple myeloma\n* Clinical diagnosis of chronic myelogenous leukemia on TKI\n* Clinical diagnosis of myelodysplastic syndrome on Lenalidomide\n* Adjuvant treatment for Gastro Intestinal Stromal Tumor\n* Clinical diagnosis of chronic Lymphocytic Leukemia\n* Clinical diagnosis of metastatic Prostate cancer\n* Clinical diagnosis of hepatocellular Carcinoma\n* Clinical diagnosis of stage IV Melanoma\n* Clinical diagnosis of myelofibrosis\u002Fmyeloproliferative neoplasms\n* Age \\>18 years\n* ECOG Performance Status \\\u003C3\n\nExclusion Criteria:\n\n* ECOG Performance Status of 3 and above\n* Concurrent chemo radiation\n* Non-English speaker\n* Clinical diagnosis of dementia, or otherwise unable to give informed consent.\n* History of non-compliance (defined as the history of 2 or more missed appointments in the clinic).\n* Pregnant patients\n* Nursing Home Patients\n* Incarcerated",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":101},"Albert Einstein Healthcare Network","Philadelphia","Pennsylvania","19141","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Claudia M Claudia M Dourado, MD","CONTACT","215-456-3880","DouradoC@einstein.edu",{"name":99,"role":95,"phone":96,"email":100},"John C Leighton, MD","leightoj@einstein.edu",{"lat":102,"lon":103},39.95238,-75.16362,[105,108],{"name":106,"role":95,"phone":96,"email":107},"Claudia M Dourado, MD","Douradoc@einstein.edu",{"name":109,"role":95,"phone":96,"email":107},"Claudia Dourado",[111],{"name":106,"affiliation":13,"role":112},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":132},[117,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Breast Carcinoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Colorectal Carcinoma","Gastrointestinal Stromal Tumor","Hepatocellular Carcinoma","Lung Non-Small Cell Carcinoma","Melanoma","Multiple Myeloma","Myelodysplastic Syndrome","Myelofibrosis","Myeloproliferative disorder","Ovarian Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":134,"prompt_version":144},{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an interventional study planning to enroll 110 participants. It will compare standard care with an enhanced education and support intervention.","completed","Improving Oral Medication Adherence in Cancer Patients","This study at Einstein Medical Center is looking at ways to help cancer patients better take their oral chemotherapy medications. Many patients in this area have diverse backgrounds, may have difficulty reading, and face financial challenges, which can make it harder to stick to their medication schedule. The study will compare standard education (information about chemotherapy drugs and side effects) with an enhanced education and support program. We want to see if these interventions improve how well patients take their oral chemotherapy over 6 months. You might be able to join if you are an adult with certain types of stage III or IV cancer and are taking oral chemotherapy agents. The study aims to enroll 110 participants.","Adherence to oral chemotherapy will be measured at 6 months.",118,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]