[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501644":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":51,"collaborators":54,"id":60,"slug":12,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":14,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":12,"enrollmentInfo":68,"targetDuration":12,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","NO_INTERVENTION","Caregiver- Survivor Dyads in this group will receive routine follow-up care in the HNC clinic. Current standard of care is an Advanced Practice Provider (Physician Assistant or Nurse Practitioner)-delivered survivorship visit after treatment. This visit will take place according to UC in the clinic. UC dyads will also receive printed caregiving and survivorship materials.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"SNAP","EXPERIMENTAL","Caregiver- Survivor Dyads in this group will receive a two-session intervention spanning 3 months, with a caregiver module within 1-2 weeks of the end of RT and a dyadic module at 3 months. Each session will include a needs- assessment, a tailored care plan with a goal setting discussion, and referrals for unmet needs. Each session follows with a supportive mobile app for 6 weeks.",[18],"Behavioral: Survivorship Needs Assessment Planning (SNAP) tool",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Survivorship Needs Assessment Planning (SNAP) tool","SNAP includes 2 educational survivorship modules for caregivers and survivors. There are 3 main elements: needs assessment, a tailored care plan and a mobile support app. SNAP uses pre-specified categories of needs, resources, and messaging \"behind the scenes\" to automate the identification, rating and management of high priority needs. Generated tailored care plans include referrals, messages and educational materials mapped to prioritized dyad-reported concerns addressing survivorship domains (diagnosis, treatment, follow-up care). Care plans and referrals are reviewed with an Advanced Practice Provider. Barriers to uptake are addressed, goal-oriented action planning is refined with brief mobile app training. Dyads receive a personalized binder with care plan, referrals, and an action plan. Dyads receive e-monitoring for 6 weeks to check in and identify barriers with algorithm-driven messaging to reinforce progress, provide further resources and encouragement.",[14],[14],[27],{"name":28,"affiliation":5,"role":29},"Katherine R Sterba, PhD, MPH","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","8438762419","sterba@musc.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Charleston","South Carolina","29425","United States",{"type":43,"coordinates":44},"Point",[45,46],-79.93275,32.77632,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":33,"phoneExt":12,"email":34},"Katherine Sterba, PhD, MPH",{"type":29,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Katherine Sterba","Professor • COM PHS Administration CC",[55,58],{"name":56,"class":57},"National Institutes of Health (NIH)","NIH",{"name":59,"class":57},"National Cancer Institute (NCI)","100501644",false,"NCT05811936","The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads","A Randomized Controlled Trial to Evaluate the Survivorship Needs Assessment Planning (SNAP) Tool for Head and Neck Cancer Survivor-Caregiver Dyads","Patient Inclusion Criteria:\n\n1. Age \\>18\n2. Stage I-IV non-metastatic HNC (i.e., lip\u002Foral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, larynx and cutaneous cancers)\n3. Currently receiving radiation treatment (with\u002Fwithout surgery and\u002For concurrent chemotherapy) with curative intent\n4. Able to nominate caregiver, the primary support person, also interested in participating\n\nCaregiver Inclusion Criteria:\n\n1. Age \\>18\n2. Provide care for a loved one with stage I-IV HNC\n3. Agrees to participate after being nominated\n\nPatient Exclusion Criteria:\n\n1. Patients who do not read\u002Funderstand English\n2. Patients who are cognitively impaired and cannot complete interviews as judged by the referring health care provider\n3. Patients concurrently diagnosed with and\u002For receiving treatment for a second \"significant\" primary cancer, except the following:\n\n   * Excised and cured non-melanoma skin cancer\n   * Carcinoma in situ of breast or cervix\n   * Superficial bladder cancer\n   * Stage 1 differentiated thyroid cancer that is resected or observed\n   * pT1a\u002FpT1b prostate cancer comprising \\\u003C5% of resected tissue with normal prostate specific antigen (PSA) since resection\n   * cT1a\u002FcT1b prostate cancer treated with brachytherapy\n\nCaregiver Exclusion Criteria:\n\n1. Inability to read or understand English\n2. Cognitively impaired and cannot complete interviews, as judged by the referring health care provider","ALL","18 Years",{"count":69,"type":70},352,"ESTIMATED","INTERVENTIONAL",[73],"NA","In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be randomized to either Survivorship Needs Assessment Planning (SNAP) or Usual Care (UC) groups to examine the effects of SNAP on outcomes. SNAP includes two sessions with a needs assessment and tailored care plan and a supportive mobile app after completion of radiation to promote uptake of recommended medical and supportive care. The study aims to evaluate the effects of SNAP on symptom severity in patients and caregiver burden in caregivers. Secondary outcomes include psychological distress (anxiety and depression), healthcare utilization (receipt of recommended care) and unmet needs and self-efficacy in HNC survivor-caregiver dyads. Participants will complete surveys at baseline, 6 months, and 9 months post randomization with validated PROMs, and receive intervention modules at the end of radiation and month 3. Participants in the SNAP group will also receive mobile app support.",[76,77,78,79],"Head and Neck Cancer","Survivorship","Caregiver Burden","Head and Neck Neoplasms",[76,77],"2026-06-09",{"date":83,"type":84},"2026-06-11","ACTUAL",{"date":86,"type":84},"2023-08-23",{"date":88,"type":70},"2027-12-31",{"name":5,"class":6},1]