[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637338":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":93,"collaborators":95,"id":100,"slug":18,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":9,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":18,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":129,"whyStopped":18,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TIMELY REHAB","EXPERIMENTAL","Participants will undergo regular standard of care for swallowing with increased access to hearing and other rehabilitative services through a proactive screening and referral program.",[13],"Other: TIMELY REHAB",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Participants will undergo regular standard of care for swallowing. In this arm, hearing and other rehabilitation care is reactive in response to a problem noticed by the patient and their care team.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"OTHER","Participants randomized to the TIMELY REHAB arm receive a coordinated cancer rehabilitation program that includes:\n\nIntensive Dysphagia Therapy (IDT): Participants receive the VA's standard-of-care swallowing therapy for patients with head and neck cancer.\n\nOtotoxicity Management: This comprehensive program provides ototoxicity screening and referral services to support auditory and balance health. It incorporates patent-pending, patient-specific ototoxicity forecasting and identification models alongside chairside high-frequency audiometry, delivered using store-and-forward tele-audiology.\n\nScreening for Other Rehabilitation Needs: Additional assessments are conducted to address a range of rehabilitation concerns, such as pain, mental health, and mobility. These are delivered via telehealth visits by an advanced practice oncology nurse using the VA-validated Cancer Rehabilitation (CaRe) Screen, supporting a holistic intervention consistent with the VA's Whole Health model.",[9],[25],{"name":26,"affiliation":27,"role":28},"Dawn L Konrad-Martin, PhD","VA Portland Health Care System, Portland, OR","PRINCIPAL_INVESTIGATOR",[30,35],{"name":26,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","(503) 220-8262","52962","Dawn.Martin@va.gov",{"name":36,"role":31,"phone":37,"phoneExt":18,"email":38},"Michelle E Hungerford, AuD","(503) 721-1089","michelle.hungerford@va.gov",[40,58,74],{"facility":41,"status":18,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.89862,35.99403,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":56,"phoneExt":18,"email":57},"Candice Quinn, PhD","919-286-0411","candice.quinn@va.gov",{"facility":27,"status":18,"city":59,"state":60,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Portland","Oregon","97207-2964",{"type":48,"coordinates":63},[64,65],-122.67621,45.52345,{"lat":65,"lon":64},[68,73],{"name":69,"role":31,"phone":70,"phoneExt":71,"email":72},"Danielle N Beaudry, MA","503-220-8262","57524","danielle.beaudry@va.gov",{"name":26,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":75,"status":18,"city":76,"state":77,"zip":78,"country":45,"countryCode":46,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",{"type":48,"coordinates":80},[81,82],-89.40123,43.07305,{"lat":82,"lon":81},[85,89],{"name":86,"role":31,"phone":87,"phoneExt":18,"email":88},"Nicole Rogus-Pulia, PhD","708-699-8615","npulia@wisc.edu",{"name":90,"role":31,"phone":91,"phoneExt":18,"email":92},"Joanne Yee, MS","6082807000","Joanne.Yee@va.gov",{"type":94,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[96,98],{"name":97,"class":6},"William S. Middleton Memorial Veterans Hospital",{"name":99,"class":6},"Durham VA Health Care System","100637338",false,"NCT07622407","Maximizing Quality of Life After Cancer Through Rehabilitation","A Transdisciplinary Interventions to MaximizE QuaLitY of Life After Cancer Through REHABilitation (TIMELY REHAB)","Inclusion Criteria:\n\nParticipants must be:\n\n* diagnosed with head and neck malignancy within the past 60 days;\n* prescribed a treatment plan at participating site that includes at least 1 dose of a cisplatin-based chemotherapy, or at least one dose of radiotherapy and\u002For surgery;\n* prescribed Intensive Dysphagia Therapy (IDT) at the participating site;\n* sufficient fluency in written English to be able to complete the study patient reported outcome questionnaires.\n\nExclusion Criteria:\n\nParticipants will be excluded is they have:\n\n* distant metastasis at enrollment;\n* diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment;\n* prior or planned total laryngectomy;\n* prior or planned cochlear implant;\n* head and neck radiotherapy for thyroid or cutaneous\u002Fskin primary tumors, regardless of neck fields;\n* cognitively or physically unable to participate (patient, physician or nurse report patient is incapable of participating), medical records indicate that participant exhibits aggressive behavior, participant has documented dementia, Alzheimer's disease, or severe psychosocial disorder, or notes indicate an individual is not legally capable of providing informed consent (participant has a legal guardian);\n* moderate\u002Fsevere dysphagia at enrollment per baseline videofluoroscopy DIGEST grade \\>=2;\n* severe\u002Fprofound hearing loss at enrollment per baseline audiogram;\n* exhibits Meniere's disease or retrocochlear disorder based on baseline hearing test results, patient report or notes in electronic medical records;\n* exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, baseline hearing test results, patient report, or medical record documentation;\n* unwilling to participate.","ALL","18 Years","89 Years",{"count":110,"type":111},74,"ESTIMATED","INTERVENTIONAL",[114],"NA","Treatment for head and neck cancer (HNC) often includes cisplatin chemotherapy and radiation. This treatment causes hearing loss and trouble swallowing in 70% of patients. If untreated, these symptoms increase stress and lower quality of life for survivors. Veterans with HNC usually get help for swallowing. However, damage to the hearing and balance systems-known as ototoxicity-is often missed or only addressed when it becomes very severe. To fill this gap, the investigators plan a clinical trial at two VA sites. The investigators compare the usual swallowing therapy alone to a new, more comprehensive program. This new program includes:\n\n1. the standard swallowing therapy,\n2. proactive management to protect hearing and balance or manage problems that can't be prevented, and\n3. other rehabilitation services based on a tele-oncology nurse's assessment. The hearing and balance intervention features quick screening tests and validated questionnaires to identify early signs of damage. These are given during cancer or radiation treatment visits to maximize convenience for the patient. Audiologists review these results remotely using tele-health technology. The investigators will also use new tools to predict and spot hearing problems that are personalized for each patient. The audiologist works closely with the patient and the care team to arrange further help if needed.\n\nThe tele-oncology nurse checks for other rehabilitation needs using a screening tool validated in Veterans, shares this information with the team, and advises patients about recommended care.\n\nThe investigators expect the results to show that managing hearing loss with swallowing therapy while improving care coordination for rehabilitation reduces survivors' stress and improves well-being compared to swallowing therapy alone.",[117,118,119,120],"Head and Neck Cancer","Hearing Loss","Tinnitus","Dysphagia",[122,123,124,125,117,126,120,127,128,119],"Audiology","Chemotherapy","Cisplatin","Drug-related side effects and adverse reactions","Ototoxicity","Professional practice gaps","Sensorineural hearing loss","NOT_YET_RECRUITING","2026-05-27",{"date":132,"type":133},"2026-06-03","ACTUAL",{"date":135,"type":111},"2027-03-01",{"date":137,"type":111},"2030-06-30",{"name":5,"class":6},3]