[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07428278":3,"trial-entities:NCT07428278":103,"trial-summary:NCT07428278":107},{"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":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":100,"references":101,"see_also_links":102},"NCT07428278","2023-0430: Aim 4-6","Resilience-Building for Advance Care Planning","Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention: A Randomized Controlled Trial.","RECRUITING","2028-07-31","2026-02","2026-06-09","2026-05-28","University of Illinois at Chicago","OTHER",true,"The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.","Patients with advanced cancer have not fully benefited from advance care planning due to the high levels of anxiety and depression experienced and other barriers that affect their appraisals and coping. Despite the protective effects of resilience, there have been few clinical trials improving the resilience skills of patients with advanced cancer and their family caregivers to help initiate advance care planning discussions and sustain engagement. This research evaluates the impact of a web-based resilience-building intervention called ROCKS on enhancing the completion of advance directives, as well as improving resilience, coping, anxiety, and depression among patients with advanced cancer and their family caregivers.",[19,20],"Advanced Cancer","End of Life",[22,23],"Resilience","Advance Care Planning","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},152,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","ROCKS","The intervention will be provided to participants to strengthen optimism, communication skills, knowledge, and self-efficacy to support patients and family caregivers in engaging in advance care planning discussions.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Usual Care","An advance directive called Five Wishes will be provided to participants to increase their knowledge about advance care planning.",[38],[42],{"measure":43,"description":44,"timeFrame":45},"Completion of advance directives","Completion of Five Wishes","Week 8",[47,49,52,55,58,61,64],{"measure":22,"description":48,"timeFrame":45},"Assessed using the Connor-Davidson Resilience Scale (Range: 0-100; higher scores indicate a greater level of resilience)",{"measure":50,"description":51,"timeFrame":45},"Optimism","Assessed using the Revised Compound PsyCap Scale (Range: 3-18; higher scores indicate a greater level of optimism)",{"measure":53,"description":54,"timeFrame":45},"Dyadic communication and coping","Assessed using the Dyadic Coping Inventory (Range: 35-175; higher scores indicate greater perceived communication and dyadic coping)",{"measure":56,"description":57,"timeFrame":45},"Knowledge","Assessed using the Advance Care Planning Engagement Survey (Range: 2-10; Higher scores indicate a greater knowledge of advance care planning)",{"measure":59,"description":60,"timeFrame":45},"Self-efficacy","Assessed using the Advance Care Planning Engagement Survey (Range: 12-50; Higher scores indicate greater self-efficacy in advance care planning)",{"measure":62,"description":63,"timeFrame":45},"Anxiety","Assessed using the Generalized Anxiety Disorder-7 (Range: 0-21; Higher scores indicate higher levels of anxiety)",{"measure":65,"description":66,"timeFrame":45},"Depression","Assessed using the Patient Health Questionnaire-9 (Range: 0-27; Higher scores indicate higher levels of depression)","ALL","18 Years","80 Years",false,{"inclusion":72,"exclusion":75,"raw_text":77},[73,74],"Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.","Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.",[76],"Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score \\\u003C 8; or (2) have completed any form of advance directive.","Inclusion Criteria:\n\n* Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.\n* Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.\n\nExclusion Criteria:\n\n* Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score \\\u003C 8; or (2) have completed any form of advance directive.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"University of Illinois Chicago","Chicago","Illinois","60607","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Li-Ting H. Longcoy","CONTACT","312-996-3024","liting@uic.edu",{"lat":95,"lon":96},41.85003,-87.65005,[98],{"name":99,"role":91,"phone":92,"email":93},"Li-Ting Longcoy",[],[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Malignant Neoplasm",[],{"nct_id":4,"found":70,"summary":108,"prompt_version":108},null]