[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05842902":3,"trial-entities:NCT05842902":112,"trial-summary:NCT05842902":116},{"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":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":51,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":84,"locations":87,"central_contacts":102,"overall_officials":105,"references":106,"see_also_links":111},"NCT05842902","STUDY00004006","Resilience Mobile App for Teens and Young Adults With Cancer","Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer","RECRUITING","2027-08-01","2026-07","2026-08-03","2023-09-12","Seattle Children's Hospital","OTHER",false,"The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.","Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested.\n\nPRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.",[19],"Cancer",[21,22,23,24,25],"Mobile health","Quality of life","Adolescent","Young Adult","Psychosocial factors","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},80,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","mPRISM","PRISM is a brief, 1:1, skills-based resilience intervention delivered in-person by trained layperson coaches. PRISM's development was based on iterative research within the AYA oncology population, stress and coping theory, resilience theory, and successful cognitive-behavioral and mindfulness interventions. mPRISM is a digital version of the PRISM program with no in-person delivery. mPRISM includes coping skills modules: managing stress, goal-setting, cognitive reframing, and meaning-making.",[39,36],"Waitlist control",[41,45,48],{"measure":42,"description":43,"timeFrame":44},"Acceptability of intervention","The Acceptability of Intervention Measure (AIM) is a well-validated 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Scale ranges from 4 to 20; higher scores are better.","immediately post-intervention",{"measure":46,"description":47,"timeFrame":44},"Appropriateness of intervention","The Intervention Appropriateness Measure (IAM) is a well-validated 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and\u002For perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better.",{"measure":49,"description":50,"timeFrame":44},"Feasibility of intervention","The Feasibility of Intervention Measure (FIM) is a well-validated 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scale ranges from 4 to 20; higher scores are better.",[52,55,59,62,65],{"measure":53,"description":54,"timeFrame":44},"Usability of intervention","The System Usability Scale (SUS) is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥70 considered adequate usability.",{"measure":56,"description":57,"timeFrame":58},"Change in health-related quality of life","The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life (HRQOL) of AYAs with cancer. Queries assess physical, emotional, social, and school well-being, plus cancer-related pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better HRQOL.","immediately post-intervention, 3 months post-intervention",{"measure":60,"description":61,"timeFrame":58},"Change in resilience","The CD-RISC is a well-validated and widely used 10-item instrument to measure inherent resiliency. Questions revolve around personal problem-solving and approaches to adversity. Scores range from 0-40, with higher scores indicating higher resilience.",{"measure":63,"description":64,"timeFrame":58},"Change in distress","This 6-item scale measures \"level of psychological distress experienced in the past month.\" The instrument strongly discriminates between community cases and non-cases of Diagnostic and Statistical Manual of Mental Disorder (DSM)-V psychiatric disorders such as serious emotional distress or serious mental illness. Scores range from 0-24, with higher scores indicating higher distress.",{"measure":66,"description":67,"timeFrame":58},"Change in anxiety and depression","7 items assess symptoms of anxiety and depression, respectively, in patients with serious illness. It has been validated in AYAs with chronic illness and cancer survivors, with excellent reliability (α=0.83-0.82). Items are scored 0-3 (subscale range 0-21), with scores ≥8 categorized as borderline abnormal, and ≥11 categorized as abnormal.","ALL","12 Years","25 Years",{"inclusion":72,"exclusion":77,"raw_text":83},[73,74,75,76],"Age 12-25 years","Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and\u002For radiation therapy at Seattle Children's Hospital (SCH)","Patient able to speak\u002Fread\u002Fwrite English or Spanish language","Cognitively able to participate in mHealth psychosocial intervention and interactive interviews",[78,79,80,81,82],"Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age","Patients with diagnosis of malignancy \\>12 months","Patients with relapsed, recurrent, or refractory disease","Patient without chemotherapy and\u002For radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)","Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys","Inclusion Criteria:\n\n* Age 12-25 years\n* Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and\u002For radiation therapy at Seattle Children's Hospital (SCH)\n* Patient able to speak\u002Fread\u002Fwrite English or Spanish language\n* Cognitively able to participate in mHealth psychosocial intervention and interactive interviews\n\nExclusion Criteria:\n\n* Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age\n* Patients with diagnosis of malignancy \\>12 months\n* Patients with relapsed, recurrent, or refractory disease\n* Patient without chemotherapy and\u002For radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)\n* Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys",[85,86],"CHILD","ADULT",[88],{"facility":13,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"Seattle","Washington","98105","United States",[94],{"name":95,"role":96,"phone":97,"email":98},"Nancy Lau, PhD","CONTACT","206-884-8238","nancy.lau@seattlechildrens.org",{"lat":100,"lon":101},47.60621,-122.33207,[103],{"name":95,"role":96,"phone":104,"email":98},"206-884-0569",[],[107],{"pmid":108,"type":109,"citation":110},"39079108","DERIVED","Lau N, Palermo TM, Zhou C, Badillo I, Hong S, Aalfs H, Yi-Frazier JP, McCauley E, Chow EJ, Weiner BJ, Ben-Zeev D, Rosenberg AR. Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jul 30;13:e57950. doi: 10.2196\u002F57950.",[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Malignant Neoplasm",[],{"nct_id":4,"found":117,"summary":118,"prompt_version":127},true,{"design":119,"status":120,"heading":6,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional study planning to enroll 80 participants. It will use a waitlist control design, meaning some participants will receive the intervention right away, and others will receive it later.","completed","This study is testing a mobile app called mPRISM, which is a version of an existing program (PRISM) that teaches skills to help teens and young adults (ages 12-25) cope with stress, set goals, and use mindfulness during cancer treatment. The goal is to see if mPRISM is easy to use, helpful, and if it can improve your quality of life and reduce mental health symptoms like anxiety or depression. You may be able to join if you are 12-25 years old, have been diagnosed with a new cancer within the last year, are receiving chemotherapy or radiation at Seattle Children's Hospital, and can speak\u002Fread\u002Fwrite English or Spanish. This study is currently unclear on its recruitment status.","The primary goals of the study, like how acceptable, appropriate, and feasible the intervention is, will be measured immediately after the intervention. Longer-term follow-up is not specified.",117,"Participants will engage in a mobile health psychosocial intervention and interactive interviews. The exact number of visits or duration is not specified in the trial record.","Not stated in the trial record.",[36],"v2"]