[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04003051":3,"trial-entities:NCT04003051":114,"trial-summary:NCT04003051":117},{"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":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":51,"secondary_outcomes":56,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":70,"locations":73,"central_contacts":104,"overall_officials":107,"references":109,"see_also_links":110},"NCT04003051","2018-1022","Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies","Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings","RECRUITING","2026-12-31","2026-04","2026-04-15","2019-03-18","M.D. Anderson Cancer Center","OTHER",false,"This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.","PRIMARY OBJECTIVE:\n\nI. To determine the impact of a web-based adherence program (PREPARE) on self-reported swallowing function in head and neck cancer patients during radiation.\n\nSECONDARY OBJECTIVE:\n\nI. To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.\n\nEXPLORATORY OBJECTIVE:\n\nI. To promote the long-term dissemination of the Dysphagia Prevention program through measurement of patient satisfaction and engagement metrics, training and continual feedback between the MD Anderson Cancer Center (MDACC) research site and community collaborative research sites.\n\nOUTLINE:\n\nPatients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.\n\nAfter completion of study, patients are followed up at 6 months.",[19],"Throat Carcinoma",[21,22,23,24,25,26,27,28],"Head and neck cancer","swallowing","trismus","adherence","coping","rural","website","access","INTERVENTIONAL","SUPPORTIVE_CARE",[32],"PHASE2",{"count":34,"type":35},300,"ESTIMATED",[37,42,48],{"type":14,"name":38,"description":39,"armGroupLabels":40},"Internet-Based Intervention","Use Project Prepare website",[41],"Supportive Care (Project Prepare website)",{"type":14,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Quality-of-Life Assessment","Ancillary studies",[41],[47],"Quality of Life Assessment",{"type":14,"name":49,"description":44,"armGroupLabels":50},"Questionnaire Administration",[41],[52],{"measure":53,"description":54,"timeFrame":55},"Changes in self-reported swallowing function","Assessed with the MD Anderson Dysphagia Inventory (MDADI). Will first test for changes in self-reported swallowing function outcome with the MDADI between baseline and follow-up using one-tailed paired t-tests. Correlations and multivariate analyses regressing self-reported adherence to exercises against self-reported swallowing function will be analyzed similarly and appropriately.","Baseline up to 6 months post-radiation",[57],{"measure":58,"description":59,"timeFrame":60},"Website usage data","Piwik analytics will be used to record usage data regarding patient engagement with the website (e.g. whether the patient looked at the website that week, number of minutes and number of navigations and pages visited).","Up to 6 months post-radiation","ALL","18 Years",null,{"inclusion":65,"exclusion":68,"raw_text":69},[66,67],"Receiving radiation treatment with curative intent for throat cancer","Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.",[],"Inclusion Criteria:\n\n* Receiving radiation treatment with curative intent for throat cancer\n* Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.",[71,72],"ADULT","OLDER_ADULT",[74,92],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"Texas Health Care-Otolaryngology and Plastic Surgery Associates","Fort Worth","Texas","76104","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Katrina M. Jensen","CONTACT","817-920-0484","info@practicalslpinfo.com",{"name":87,"role":88},"Eileen H. Shinn","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},32.72541,-97.32085,{"facility":93,"status":8,"city":94,"state":77,"zip":95,"country":79,"contacts":96,"geoPoint":101},"M D Anderson Cancer Center","Houston","77030",[97,100],{"name":87,"role":83,"phone":98,"email":99},"713-745-0870","eshinn@mdanderson.org",{"name":87,"role":88},{"lat":102,"lon":103},29.76328,-95.36327,[105],{"name":106,"role":83,"phone":98,"email":99},"Eileen H Shinn",[108],{"name":106,"affiliation":13,"role":88},[],[111],{"label":112,"url":113},"MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":115,"biomarkers":116},[19],[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 300 participants.","completed","Web-Based Program for Swallowing Exercises in Throat Cancer","This study is testing a web-based program called Project Prepare. It's designed to help people with throat cancer (head and neck cancer) who are receiving radiation therapy to stick with their swallowing and jaw exercises, and to learn coping strategies. Radiation can cause long-term swallowing problems, so these exercises are very important for recovery. Researchers want to see if using Project Prepare improves your self-reported swallowing function. You can join if you are at least 18, have throat cancer, are getting radiation with the goal of a cure, and can read English or Spanish. The study is currently unclear on its recruitment status, but plans to enroll 300 people.","After completing the study, you will be followed up at 6 months.",109,"You would use the password-protected Project Prepare website on a computer, tablet, or phone for 10 weeks. This involves viewing videos, tips, recipes, and strategies.","Not stated in the trial record.",[],"v2"]