[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07696065":3,"trial-entities:NCT07696065":110,"trial-summary:NCT07696065":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":61,"locations":64,"central_contacts":106,"overall_officials":107,"references":108,"see_also_links":109},"NCT07696065","26-101","Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials","RECRUITING","2028-06-14","2026-07","2026-07-29","2026-07-10","Phoenix Children's Hospital","OTHER",false,"Although cure rates continue to rise, one in five children with cancer still die from their disease, so new therapies are urgently needed. Most advances in childhood cancer treatments have originated through clinical trial research and new therapies must be tested in early phase clinical trials. Phase 1 clinical trials are designed to focus mainly on determining whether a drug is safe, and less on how well it cures a disease. These trials may offer patients and families hope when no other options are available to treat their cancer. However, patients in these trials may also experience treatment-related side effects and earlier death. Patients and families enrolled in phase 1 clinical trials often experience increased levels of distress. This distress may result from physical effects of the disease or treatments, or from worry, sadness, or confusion when making difficult decisions related to care or end-of-life.\n\nPediatric palliative care (PPC) is a field that aims to ease physical, psychological, emotional, and spiritual suffering and may be beneficial to patients and families enrolling in phase 1 clinical trials. Over the past decade, PPC has been shown to improve quality of life, patient and family healthcare understanding and satisfaction, communication, shared-medical decision making, advanced care planning, and healthcare cost savings. Despite evidence showing the benefits of PPC, it is not used consistently in pediatric oncology care, particularly in the setting of early phase clinical trials. Including PPC experts is a proven way to improve access to specialty care for vulnerable populations. In this application, investigators propose a study to test the feasibility, acceptability, and potential impact of including PPC consultation for pediatric cancer patients and their families during their enrollment in phase 1 clinical trials.","The proposed single-arm pilot study will use a prospective, longitudinal design conducted across three urban, tertiary care hospitals offering pediatric oncology phase 1 clinical trials (Phoenix Children's, St. Jude Children's Research Hospital, and the National Institutes of Health). These centers were chosen for their geographical diversity and variability in infrastructure and PPC resources to allow for generalizability of findings.\n\nAim 1: To assess the feasibility of integrating PPC consultation during eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial.\n\nMeasures: Feasibility of the intervention (PPC consultation) will be assessed using the Feasibility of Intervention Measure (FIM), a high quality, 4-item implementation indicator, to be completed by caregivers of pediatric oncology patients (with or without patient, if patient aged ≥12 years) enrolling in phase 1 clinical trials and their respective oncologists. Additional measures will assess recruitment (total patients\u002Fcaregivers screened, percent of patients\u002Fcaregivers eligible to participate in the study, percent of patients\u002Fcaregivers who assent\u002Fconsent to study participation), and adherence (the proportion of study assessments completed, and the length of time required to complete study assessments).\n\nHypothesis: Integration of a PPC consultation at eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial will be feasible, meeting the following targets: mean FIM score of ≥ 3 (coded 1-5) for \\> 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients\u002Fcaregivers will assent\u002Fconsent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. These target estimates are extrapolated from our preliminary work with this patient population.\n\nAim 2: To evaluate the acceptability of a PPC consultation with oncologists and caregivers of pediatric patients with cancer during phase 1 clinical trial enrollment.\n\nMeasures: Acceptability of the intervention, (PPC consultation) will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item tool administered to caregivers of patients enrolled in phase 1 clinical trials (+\u002F- patients if ≥ 12 years) and their respective oncologists. Additional measures will assess attrition (the proportion of enrolled patients lost to follow-up\u002Fwithdrawal).\n\nHypothesis: Integration of a PPC consultation at eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial will be acceptable, with a mean AIM score of ≥ 3 (coded 1-5) for \\> 70% of caregivers and oncology providers.\n\nAim 3: To assess patient\u002Fcaregiver perceptions of the impact of a PPC consultation on quality of life and facilitators\u002Fbarriers to PPC consultation integration into the standard of care for pediatric patients with cancer enrolling on phase 1 clinical trials. Methods: Investigators will conduct semi-structured qualitative interviews with caregivers (+\u002F- patients if ≥ 12 years) enrolled in phase 1 clinical trials following the completion of a PPC consult by asking: What was the impact of a PPC consultation at the time of enrollment in a phase 1 clinical trial on the quality of life of the participant? These interviews will also explore barriers and facilitators to PPC consultation at this timepoint. Investigators will thematically analyze the audio-recorded interviews. Investigators will also administer the PROMIS-Pediatric Profile-2510, a validated tool for caregivers, children, and adolescents (≥ 8 years), to assess the potential impact of the intervention on health-related quality of life.\n\nAim 4: To explore Oncologist perspectives on effective peer communication strategies for encouraging PPC involvement in Phase 1 Oncology trials, at study completion, we will invite oncologists who participated in the study to participate in an optional one time 15-minute semi structured recorded interview.",[18],"Quality of Life Outcomes",[20,21,22],"pediatric","palliative care","phase 1 oncology trials","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"EARLY_PHASE1",{"count":28,"type":29},30,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Pediatric Palliative Care Consultation","Formal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial. Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.",[33],[37,41],{"measure":38,"description":39,"timeFrame":40},"Feasibility","Feasibility will be defined as a mean FIM score of ≥ 3 (coded 1-5) for \\> 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients\u002Fcaregivers will assent\u002Fconsent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. Themes identified from qualitative findings, specifically from caregivers\u002Fpatients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.","2 years",{"measure":42,"description":43,"timeFrame":44},"Acceptability","Acceptability will be defined as a mean AIM score of ≥ 3 (coded 1-5) for \\> 70% of caregivers and oncology providers. Themes identified from qualitative findings, specifically from caregivers\u002Fpatients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.","two years",[46,49],{"measure":47,"description":48,"timeFrame":44},"Barriers and Facilitators to Palliative Care Integration","To assess participants' perceptions of how PPC integration at the time of phase 1 trial enrollment impacted quality of life and facilitators\u002Fbarriers to PPC consultation, investigators will conduct a one-time, semi-structured interview with the caregiver\u002Fpatient (\\> 12 years) within 1 week following the third PPC visit or phase 1 study completion.",{"measure":50,"description":51,"timeFrame":44},"Impact on quality of life","Investigators will administer the PROMIS-Pediatric Profile-25 survey (Patient-Reported Outcomes Measurement Information System) at baseline and within 1 week following the third PPC visit or phase 1 study completion. Patients' reported outcomes in the context of the PPC intervention will be assessed, including mobility, anxiety, depression, fatigue, peer relationships, and pain interference\u002Fintensity. This tool was validated for adolescents aged ≥ 8 years, translated into several languages for non-English-speaking participants, and requires 5-10 minutes for completion.\n\nPROMIS results are always reported on a T-score metric, which compares participants' results to a reference population (usually the U.S. general population). The greater the score, the more severe the symptoms (i.e. Less than 55: Normal or better-than-average; 55 - 60: Mild symptoms; 60 - 70: Moderate symptoms; Greater than 70: Severe symptoms).","ALL","0 Years","25 Years",{"inclusion":56,"exclusion":58,"raw_text":60},[57],"Patients (aged 0-25 years) diagnosed with cancer and undergoing evaluation for enrollment in a phase 1 trial, their caregivers, as well as their primary treating oncologist are eligible for study participation.",[59],"Previous palliative care exposure","Inclusion Criteria:\n\n* Patients (aged 0-25 years) diagnosed with cancer and undergoing evaluation for enrollment in a phase 1 trial, their caregivers, as well as their primary treating oncologist are eligible for study participation.\n\nExclusion Criteria:\n\n* Previous palliative care exposure",[62,63],"CHILD","ADULT",[65,79,93],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"Phoenix","Arizona","85016","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Mikaela Rollins, BS","CONTACT","602-933-0715","mrollins@phoenixchildrens.com",{"lat":77,"lon":78},33.44838,-112.07404,{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":69,"contacts":85,"geoPoint":90},"National Institutes of Health","NOT_YET_RECRUITING","Bethesda","Maryland","20814",[86],{"name":87,"role":73,"phone":88,"email":89},"Brian Pennarola, MD","240-760-7250","Brian.pennarola@nih.gov",{"lat":91,"lon":92},38.98067,-77.10026,{"facility":94,"status":81,"city":95,"state":96,"zip":97,"country":69,"contacts":98,"geoPoint":103},"St. Jude Children's Research Hospital","Memphis","Tennessee","38105",[99],{"name":100,"role":73,"phone":101,"email":102},"Erica Kaye, MD, MPH","901-595-8188","erica.kaye@stjude.org",{"lat":104,"lon":105},35.14953,-90.04898,[],[],[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Malignant Neoplasm",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":125},true,{"design":117,"status":118,"heading":6,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is a single-arm study, meaning all participants will receive the same intervention. It aims to enroll 30 participants.","completed","This study is looking at how well integrating Palliative Care Consultation (PPC) works for children and young adults (ages 0-25) with cancer who are considering joining a Phase 1 clinical trial. Phase 1 trials test new treatments mainly to see if they are safe. We want to see if having a specialized PPC doctor involved early on is practical and helpful for patients, their families, and their oncologists. The study aims to enroll 30 participants and is currently unclear about its recruitment status. Success will be measured by how feasible (practical) and acceptable this approach is over two years.","The study will assess feasibility and acceptability over two years.",99,"You would have a formal PPC consultation during the eligibility screening for the Phase 1 trial, followed by standard PPC visits every 2-4 weeks.","Not stated in the trial record.",[],"v2"]