[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651534":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":51,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":88,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FamilyStrong","EXPERIMENTAL","Caregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs.",[13],"Behavioral: FamilyStrong",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Caregivers randomized to usual care will continue to use the supportive services ordinarily available through the UAB cancer center, health system, community organizations, and their personal support networks. The study will not restrict access to social work, chaplaincy, behavioral health, palliative care, patient navigation, support groups, or other services. Participants will receive a study-approved packet describing available cancer-center and family-support resources but will not receive the monthly FamilyStrong navigator contacts during the 24-week study period.",null,[20],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":18},"BEHAVIORAL",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"J. Nicholas Odom, PhD, RN","CONTACT","205-934-7597","dionneod@uab.edu",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},"Sally Engler, MPH","205-996-7564","sengler@uab.edu",[34],{"facility":5,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Birmingham","Alabama","35294","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-86.80249,33.52066,{"lat":44,"lon":43},[47,50],{"name":48,"role":26,"phone":49,"phoneExt":18,"email":28},"James N Odom, PhD, RN","2059347597",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","James N Odom","Professor",[56],{"name":57,"class":6},"American Cancer Society, Inc.","100651534","the-familystrong-pilot-randomized-trial-100651534",false,"NCT07761988","The FamilyStrong Pilot Randomized Trial","Brief Distress Support for Family Caregivers of Persons With Advanced Cancer: The FamilyStrong Pilot Randomized Trial","Inclusion Criteria:\n\n* CAREGIVERS:\n\n  1\\) ≥18 years of age; 2) self-endorsing or identified by the patient as \"a relative, friend, or partner that has a close relationship with you and who assists with your health and medical care and who may or may not live in the same residence as you and who is not paid for their help\"; 3) caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below) who is not enrolled in hospice; 4) caregivers will NOT need to have a patient willing to participate; and 5) able to speak and read English and complete baseline measures.\n* PATIENTS:\n\n  1. ≥18 years of age; 2) screened within 60 days of an oncology visit where the patient had documentation of a new diagnosis of an advanced stage cancer, defined as metastatic and\u002For recurrent\u002Fprogressive stage III\u002FIV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies; and 3) able to speak and read English and complete baseline measures.\n\nExclusion Criteria:\n\n* CAREGIVERS:\n\n  1\\) Self-reported active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.\n* PATIENTS:\n\n  1. Receiving hospice per EHR; 2) Per EHR, active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, suicidal ideation, uncorrected hearing loss, or substance abuse.","ALL","18 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"NA","When someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most.",[75,76,77],"Family Caregivers","Distress in Caregivers of Cancer Patients","Advanced Cancer",[79,80,81,82,83,84,85,86,87],"family caregiver","cancer caregiving","caregiver support","distress screening","lay navigation","supportive care","psychosocial support","telehealth","unmet supportive care needs","NOT_YET_RECRUITING","2026-08-06",{"date":91,"type":92},"2026-08-13","ACTUAL",{"date":94,"type":69},"2027-01-01",{"date":96,"type":69},"2028-09-30",{"name":5,"class":6},1]