Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07035418
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adolescents and Young Adults With Cancer: Their Preferred Involvement in Decision Making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-15', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of Decision-Making Roles in Clinical Scenarios', 'timeFrame': 'Within 2 weeks of survey link delivery', 'description': 'Proportion of participants who select an active, collaborative, or passive role in hypothetical clinical decision-making scenarios. Each role will be counted and compared across participant subgroups.'}], 'secondaryOutcomes': [{'measure': 'Association Between Sociodemographic Characteristics and Decision-Making Role', 'timeFrame': 'At time of electronic survey completion', 'description': "This outcome assesses the association between sociodemographic characteristics (e.g., age, race/ethnicity, gender, education level, and employment status) and adolescents' and young adults' preferred treatment decision-making role. Role preference (active, collaborative, or passive) is assessed using the modified Control Preferences Scale. Sociodemographic variables are self-reported via electronic questionnaire. The unit of measure is the chi-square test statistic or ANOVA output, depending on the variable type."}, {'measure': 'Concordance Between Interview Responses and Scenario-Based Decision-Making Roles', 'timeFrame': 'At time of interview, within 4 weeks of survey completion', 'description': 'Proportion of interview responses that align with or differ from role preferences identified in hypothetical scenarios. Qualitative responses will be coded and categorized into roles for comparison.'}, {'measure': 'Correlation Between Healthcare Encounters and Decision-Making Role Preference', 'timeFrame': 'At time of interview, within 4 weeks of survey completion', 'description': "This outcome measures the correlation between the number of cancer-related healthcare encounters and adolescents' and young adults' preferred treatment decision-making role. Healthcare encounters will be abstracted from the electronic health record and include clinic visits, procedures, hospitalizations, ICU stays, and emergency department visits. Decision-making role preference (active, collaborative, or passive) will be assessed using the modified Control Preferences Scale. The unit of measure is the Pearson correlation coefficient."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Survivor', 'Adolescent and Young Adults'], 'conditions': ['Adolescent Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this mixed-methods study is to determine Adolescent and Young Adult (AYAs) decision making preferences post cancer diagnosis using vignettes designed to assess their preferred involvement in decisions about their cancer treatment and variables associated with these treatment decision-making (TDM) preferences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (15-29 years)\n* Cancer diagnosis and on therapy, end-of-life or survivors (within 1 year)\n* Speaks English\n* Reads English\n* Cognitively and physically able to participate\n\nExclusion Criteria:\n\n* Unable to participate in study due to developmental delay or developmental disorder'}, 'identificationModule': {'nctId': 'NCT07035418', 'briefTitle': 'Adolescents and Young Adults With Cancer: Their Preferred Involvement in Decision Making', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Adolescents and Young Adults With Cancer: Their Preferred Involvement in Decision Making', 'orgStudyIdInfo': {'id': 'IRB-58292'}, 'secondaryIdInfos': [{'id': 'NCI-2024-00875', 'type': 'REGISTRY', 'domain': 'National Cancer Institute Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AYA Decision-Making Role Assessment', 'description': 'Participants will complete an electronic socio-demographic questionnaire followed by a set of hypothetical clinical decision-making scenarios to assess preferred decision-making roles and involvement of healthcare providers and family/friends. Responses will inform understanding of facilitators and barriers to shared decision-making.', 'interventionNames': ['Behavioral: Clinical Decision-Making Scenarios and Preferences Assessment']}], 'interventions': [{'name': 'Clinical Decision-Making Scenarios and Preferences Assessment', 'type': 'BEHAVIORAL', 'description': 'Participants complete a socio-demographic questionnaire and decision-making preferences scale, including hypothetical clinical scenarios, to identify their preferred decision-making role (active, collaborative, or passive) and the influence of providers or family. Delivered electronically via secure link; reminders sent as needed.', 'armGroupLabels': ['AYA Decision-Making Role Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Swathi Alagandula', 'role': 'CONTACT', 'email': 'drswathi@stanford.edu', 'phone': '650-725-1976'}, {'name': 'Kimberly Pyke-Grimm', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Swathi Alagandula', 'role': 'CONTACT', 'email': 'drswathi@stanford.edu', 'phone': '650-725-1976'}], 'overallOfficials': [{'name': 'Kimberly Pyke-Grimm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}