[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07415564":3,"trial-entities:NCT07415564":110,"trial-summary:NCT07415564":117},{"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":15,"conditions":17,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":49,"secondary_outcomes":54,"sex":59,"minimum_age":60,"maximum_age":15,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":79,"locations":82,"central_contacts":98,"overall_officials":103,"references":108,"see_also_links":109},"NCT07415564","STUDY00007379","Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers","Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers","RECRUITING","2027-09","2026-07","2026-07-20","2026-05-06","University of Arizona","OTHER",null,"The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina\u002Fo, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues.\n\nThe specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads):\n\nAim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11.\n\nAim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone.\n\nAim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone.\n\nThe proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.",[18,19,20],"Cancer Metastatic","Symptoms and Signs","Quality of Life",[22,23,24,25,26],"cancer","Metastatic cancer","Symptom management","Cancer survivorship","Cancer caregivers","INTERVENTIONAL","SUPPORTIVE_CARE",[30],"NA",{"count":32,"type":33},200,"ESTIMATED",[35,42],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BEHAVIORAL","Symptom Management and Survivorship Handbook + Coaching","Coaches call survivors and caregivers separately each week. In week one, they introduce themselves and the intervention, explain the 10-call structure, and help participants prioritize symptoms and set management goals. Coaches review SMSH recommendations, coach on symptom management strategies, and use techniques such as motivational interviewing and self-monitoring. Coaches remind participants that some strategies help multiple symptoms, and recommend talking to a provider if any symptom scores above 3. In sessions 2-10, coaches check in, administer a symptom questionnaire, review prior goals, and document progress, barriers, and new goals. Each session covers discovery, desired outcome, pathways, context, and design.",[37],[41],"SMSH+",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":47},"Symptom Management and Survivorship Handbook","Survivors and caregivers receive a printed Symptom Management and Survivorship Handbook (SMSH), proven to help manage symptoms. The SMSH covers 24 common cancer symptoms (like fatigue, depression, sleep issues, pain), plus lifestyle, behavior, and survivorship guidelines. For 10 weeks, an interventionist calls weekly to assess symptoms and refer to relevant handbook chapters.",[46],"Symptom Management and Survivorship Handbook (SMSH)",[48],"SMSH alone",[50],{"measure":51,"description":52,"timeFrame":53},"Symptom severity","Assess whether SMSH combined with health coaching reduces the burden of 24 symptoms over 10 weeks compared to SMSH alone. Symptom burden will be measured using summary severity and interference scores from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE). Severity is rated on a scale of 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Interference is rated on a scale of 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. Frequency is rated as 0=never, 1=rarely, 2=occasionally, 3=frequently, 4=almost constantly. As outlined in the PRO-CTCAE, frequency, severity, and interference questions will be asked for each item available. If frequency is \"never,\" severity and interference will not be asked. Summary scores for severity and interference will be derived from the toxicity index (TI) developed by Rogatko et al. for CTCAE grades and applied to the PRO-CTCAE scores over weeks 1-8. Higher scores indicate worse outcomes.","10 weeks",[55],{"measure":56,"description":57,"timeFrame":58},"Health Related Quality of Life (HRQoL)","Determine whether SMSH combined with health coaching improves HRQoL (social, physical, psychological) at week 11 compared to SMSH alone. HRQoL will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-43, which is suitable for both survivors and caregivers and is available in English and Spanish. PROMIS domains include depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with participation in social roles. Each item uses a 5-point Likert scale (1-5) plus a single pain intensity rating (0-10 for direct pain assessment). The scores for each domain are not summed into a single score and are meant to be used together to reflect HRQoL domains. A T-score of 50 represents the U.S. general population average, with a standard deviation of 10. Higher scores indicate worse outcomes for symptoms\u002Finterference, but better outcomes for physical function.","11 weeks","ALL","18 Years",false,{"inclusion":63,"exclusion":73,"raw_text":78},[64,65,66,67,68,69,70,64,68,71,72],"Age 18 or older","Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer","Able to perform basic activities of daily living","Cognitively oriented to time, place, and person (recruiter determined)","Able to speak and understand English or Spanish","Access to a telephone","Has a caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can.","Telephone access","Not currently treated for cancer",[74,75,76,77],"Nursing home resident","Bedridden","Hospice care","Currently receiving a symptom management intervention","Inclusion criteria for cancer survivors:\n\n* Age 18 or older\n* Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer\n* Able to perform basic activities of daily living\n* Cognitively oriented to time, place, and person (recruiter determined)\n* Able to speak and understand English or Spanish\n* Access to a telephone\n* Has a caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can.\n\nInclusion criteria for the caregivers:\n\n* Age 18 or older\n* Able to speak and understand English or Spanish\n* Telephone access\n* Not currently treated for cancer\n\nExclusion criteria:\n\n* Nursing home resident\n* Bedridden\n* Hospice care\n* Currently receiving a symptom management intervention",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"University of Arizona Cancer Center","Tucson","Arizona","85719","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Michele Chu-Pilli, MS","CONTACT","520-626-1183","chum@arizona.edu",{"lat":96,"lon":97},32.22174,-110.92648,[99],{"name":100,"role":92,"phone":101,"email":102},"Molly Hadeed, MPA, MSPH","520-626-0583","mcbarry@arizona.edu",[104],{"name":105,"affiliation":106,"role":107},"Terry A Badger, RN, PhD","University of Arizona College of Nursing","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":116},[112,113,114,115],"Breast Carcinoma","Malignant Digestive System Neoplasm","Melanoma","Solid Neoplasm",[],{"nct_id":4,"found":118,"summary":119,"prompt_version":128},true,{"design":120,"status":121,"heading":6,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an interventional study planning to enroll 200 participants. It compares receiving a handbook alone versus receiving the handbook plus coaching.","completed","This study is looking at ways to help people with advanced cancer (metastatic or stage IV breast, gastrointestinal, or melanoma cancer) and their caregivers manage symptoms and improve their quality of life. You would receive a \"Symptom Management and Survivorship Handbook\" (SMSH) which has information on managing 24 common cancer symptoms like fatigue, depression, and pain. Some participants will also receive weekly phone calls from a coach to help them set goals and manage their symptoms. The study aims to see how much these interventions can reduce the severity of your symptoms over 10 weeks. They plan to enroll 200 participants. The current status of the study is unclear.","Symptom severity will be measured at 10 weeks.",109,"You would participate in a 10-week program. If in the coaching group, you and your caregiver would receive separate weekly phone calls from a coach.","Not stated in the trial record.",[43],"v2"]