[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494213":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":26,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":26,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Arizona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adaptive Intervention","EXPERIMENTAL","The adaptive intervention sequence is assumed to affect psychological distress (depression and anxiety) severity of other symptoms and irAEs, as tested in Aim 1. Both the Automated Telephone Symptom Management (ATSM) system and the Telephone Interpersonal Counseling (TIP-C) interventions help participants to identify and understand troublesome symptoms, with suggestions to effectively self-manage these symptoms. The proposed interventions are expected to alleviate burdensome symptoms through several key mediating variables, as tested in Aim 2.",[13],"Behavioral: Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Control","ACTIVE_COMPARATOR","Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe. An active control comparator was purposively selected to enable a more rigorous testing of intervention effectiveness in Aims 1 and 2. Also, the study team will be better able to address the question about which channel of communication (automated versus survivor initiated) results in better outcomes.",[19],"Behavioral: Active control comparator",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)","Participants randomized to the adaptive intervention are telephoned weekly and asked to enter by pin-pad or voice the severity of the PRO-CTCAE items on a 0-4 scale, with 0 being none and 4 being very severe. Participants are mailed the Symptom Management and Survivorship Handbook in their preferred language (English or Spanish). Survivors who rated any item at moderate or higher (2-4) will be referred by the ATSM to read the corresponding chapters in the Handbook and given a call back in 24 hours to inquire about the severity of the reported symptom, whether it has improved or worsened, and whether the participant reported it to their HCP, or the HCP has contacted the survivor. Participants that report elevated symptoms for two consecutive weeks are rerandomized to continue the ATSM alone or continue the ATSM with TIP-C added for 8 weeks. TIP-C is delivered by a masters prepared counselor with cancer expertise via weekly 30-minute phone calls using interpersonal techniques.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Active control comparator","Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe.",[15],[32],{"name":33,"affiliation":5,"role":34},"Terry Badger, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Molly Hadeed","CONTACT","520-626-0583","mcbarry@arizona.edu",[42,56,72],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"Valleywise Health Medical Center","ACTIVE_NOT_RECRUITING","Phoenix","Arizona","85008","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-112.07404,33.44838,{"lat":54,"lon":53},{"facility":57,"status":58,"city":59,"state":46,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University of Arizona Cancer Center","RECRUITING","Tucson","85724",{"type":51,"coordinates":62},[63,64],-110.92648,32.22174,{"lat":64,"lon":63},[67,68,71],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":69,"role":38,"phone":26,"phoneExt":26,"email":70},"UACC IIT","UACC-IIT@uacc.arizona.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":73,"status":44,"city":74,"state":75,"zip":76,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":81,"contacts":26},"University of Michigan","Ann Arbor","Michigan","48109",{"type":51,"coordinates":78},[79,80],-83.74088,42.27756,{"lat":80,"lon":79},{"type":83,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[85],{"name":86,"class":87},"National Cancer Institute (NCI)","NIH","100494213","adaptive-symptom-self-management-immunotherapy-study-100494213",false,"NCT05715255","Adaptive Symptom Self-Management Immunotherapy Study","Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Age 18 or older\n* Within 12 weeks after starting ICI treatment for cancer\n* Cognitively oriented to person, place and time (determined by recruiter)\n* Able to speak and understand English or Spanish\n* Access to a telephone\n* Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library\n\nExclusion Criteria:\n\n* Currently receiving regular behavioral counseling","ALL","18 Years",{"count":98,"type":99},400,"ESTIMATED","INTERVENTIONAL",[102],"NA","The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.",[105,106,107,108,109],"Breast Cancer","Colon Cancer","Lung Cancer","Skin Cancer","Rectum Cancer",[111,112,113,114,115,116,117],"Cancer","Cancer Survivors","Immunotherapy","Immune Checkpoint Inhibitors","Symptom Management","Psychosocial Oncology","Telephone Intervention","2026-05-11",{"date":120,"type":121},"2026-05-14","ACTUAL",{"date":123,"type":121},"2023-05-08",{"date":125,"type":99},"2027-04-30",{"name":5,"class":6},3]