[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723495":3,"trial-entities:NCT07723495":91,"trial-summary:NCT07723495":95},{"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":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":15,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":66,"locations":69,"central_contacts":85,"overall_officials":88,"references":89,"see_also_links":90},"NCT07723495","19934","Symptom Management to Improve Completion of Patient-reported Outcome Measures","Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)","NOT_YET_RECRUITING","2031-09-01","2026-07","2026-07-29","2027-10-01","Henry Ford Health System","OTHER",null,"In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and those who do not receive these (control arm). PRO measures are validated tools that capture health-related perspectives directly from the patient and are complementary to provider assessment. Timely completion of PRO assessments and symptoms management of moderate or severe symptoms are essential to improve quality of life and decrease unwanted health care utilization. However, only \\~40% of patients complete PRO assessments in clinical settings. In addition, systemic therapy for cancer results in many symptoms (e.g., dry mouth, shortness of breath, constipation) not covered by the disease-general Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Patients in the control arm will receive the existing PROMIS assessments and a thank you message upon completion. Patients in the intervention arm will receive the PROMIS assessments in addition to nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms, and evidence-based self-management strategies Handbook for those with elevated symptoms. Patients in the intervention arm will enter their symptoms in a SMS text and they will be directed to the handbook for strategies to manage their elevated symptoms using a digital platform-Computerized Intervention Authoring System (CIAS)-integrated within the Epic electronic health records. Information gathered has the potential to influence cancer care practices on a larger scale, shaping policies and clinical practices to improve health outcomes for cancer patients and reducing the burden of cancer-related symptoms.","PRIMARY OBJECTIVE:\n\n1\\. To test the effectiveness of the intervention's enhanced patient reported outcome (PRO) monitoring strategy (offer of nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms and evidence-based self-management strategies for elevated symptoms) versus the active control (receipt of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures) on PRO monitoring reach and penetration \\[PRO assessment completion\\] over 6 months.\n\nSECONDARY OBJECTIVES:\n\n1. Test the extent to which any differences in PRO monitoring reach and penetration between intervention and control arms at month 6 are explained by patient's symptom management self-efficacy and expectancy at month 3 (potential mechanisms).\n2. Test the extent to which any differences in PRO monitoring reach and penetration at month 6 between intervention and control arms differ according to patient, disease and treatment characteristics (e.g., age, site and stage of cancer, concurrent radiation therapy).",[19,20,21],"Malignant Solid Neoplasm","Malignant Head and Neck Neoplasm","Malignant Lung Neoplasm",[23,24,25],"Cancer","Symptom management","Patient-reported outcomes","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},78,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Monitoring of PROMIS symptoms and physical function","Patients will be offered to complete Patient-Reported Outcomes Measurement Information System (PROMIS) measures of symptoms and physical function prior to their scheduled clinic appointments via MyChart or on a tablet in the clinic's waiting room. The scores are recorded in their health record and available for review by health care providers.",[39,40],"Arm I (PROMIS assessment)","Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies)",{"type":35,"name":42,"description":43,"armGroupLabels":44},"Monitoring of additional symptoms and symptom self-management","Assessments of additional symptoms from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be offered via Computerized Intervention Authoring System (CIAS). For elevated symptoms, patients will be directed to use evidence-based self-management strategies from the printed Symptom Management Toolkit.",[40],[46,50],{"measure":47,"description":48,"timeFrame":49},"Reach of patient reported outcome (PRO) assessment completion","The number of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.","6 months",{"measure":51,"description":52,"timeFrame":49},"Penetration of patient reported outcome (PRO) assessment completion","The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.",[],"ALL","18 Years",false,{"inclusion":58,"exclusion":63,"raw_text":65},[59,60,61,62],"1\\) Adults (≥18 years) with a diagnosis of a malignancy of head and neck or lung cancers.","2\\) Scheduled to start infusion systemic therapy in the next 4 weeks or have started infusion systemic therapy in the past 4 weeks.","3\\) Able to read and understand English.","4\\) Cognitively oriented to person, place and time (determined by recruiter).",[64],"1\\) Unable to read and understand English.","Inclusion Criteria:\n\n* 1\\) Adults (≥18 years) with a diagnosis of a malignancy of head and neck or lung cancers.\n* 2\\) Scheduled to start infusion systemic therapy in the next 4 weeks or have started infusion systemic therapy in the past 4 weeks.\n* 3\\) Able to read and understand English.\n* 4\\) Cognitively oriented to person, place and time (determined by recruiter).\n\nExclusion Criteria:\n\n* 1\\) Unable to read and understand English.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Henry Ford Health","Detroit","Michigan","48202","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Eric Adjei Boakye, PhD","CONTACT","(313) 874-6218","eadjei1@hfhs.org",{"lat":83,"lon":84},42.33143,-83.04575,[86],{"name":78,"role":79,"phone":87,"email":81},"313-874-6218",[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93,20],"Lung Carcinoma",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":107},true,{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study planning to enroll 78 participants. It compares two groups: one receiving enhanced symptom monitoring and self-management strategies, and another receiving standard monitoring.","completed","Symptom Management for Head and Neck or Lung Cancer Patients","This study is for adults (18 and older) with head and neck or lung cancer who are starting or have recently started infusion therapy. It aims to see if offering extra symptom monitoring and self-management tips helps patients complete surveys about their health (called Patient-Reported Outcomes or PROs). You would either receive these extra tools (the intervention arm) or just the standard symptom monitoring (the control arm). Researchers want to see if the extra tools lead to more patients completing these important surveys over 6 months. There are no specific biomarkers required to join.","The primary goals of the study are measured at 6 months.",94,"You would be offered to complete PRO surveys before clinic appointments, either through MyChart or on a tablet. If in the intervention group, you would also be offered assessments for additional symptoms and directed to self-management strategies for elevated symptoms.","Not stated in the trial record.",[],"v2"]