Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT05842902
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2023-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resilience Mobile App for Teens and Young Adults With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized waitlist design: AYAs will be randomized 1:1 to psychosocial Usual Care (UC) or UC plus mPRISM. mPRISM will be provided to UC arm at 3-month follow-up.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of intervention', 'timeFrame': 'immediately post-intervention', 'description': '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.'}, {'measure': 'Appropriateness of intervention', 'timeFrame': 'immediately post-intervention', 'description': '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/or perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better.'}, {'measure': 'Feasibility of intervention', 'timeFrame': 'immediately post-intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Usability of intervention', 'timeFrame': 'immediately post-intervention', 'description': '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': 'Change in health-related quality of life', 'timeFrame': 'immediately post-intervention, 3 months post-intervention', 'description': '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.'}, {'measure': 'Change in resilience', 'timeFrame': 'immediately post-intervention, 3 months post-intervention', 'description': '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': 'Change in distress', 'timeFrame': 'immediately post-intervention, 3 months post-intervention', 'description': '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': 'Change in anxiety and depression', 'timeFrame': 'immediately post-intervention, 3 months post-intervention', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile health', 'Quality of life', 'Adolescent', 'Young Adult', 'Psychosocial factors'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '39079108', 'type': 'DERIVED', 'citation': '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: 10.2196/57950.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 12-25 years\n* Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)\n* Patient able to speak/read/write 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/or 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"}, 'identificationModule': {'nctId': 'NCT05842902', 'briefTitle': 'Resilience Mobile App for Teens and Young Adults With Cancer', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer', 'orgStudyIdInfo': {'id': 'STUDY00004006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mPRISM', 'description': 'The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys.', 'interventionNames': ['Behavioral: mPRISM']}, {'type': 'OTHER', 'label': 'Waitlist control', 'description': 'Usual Care (UC) available to both study arms consists of standard non-directed supportive care provided for all patients including an assigned social worker throughout cancer treatment. In a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys.', 'interventionNames': ['Behavioral: mPRISM']}], 'interventions': [{'name': 'mPRISM', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Waitlist control', 'mPRISM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Lau, PhD', 'role': 'CONTACT', 'email': 'nancy.lau@seattlechildrens.org', 'phone': '206-884-8238'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Nancy Lau, PhD', 'role': 'CONTACT', 'email': 'nancy.lau@seattlechildrens.org', 'phone': '206-884-0569'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nancy', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}