Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-06-27 @ 11:07 PM
Study NCT ID:
NCT03599661
Status:
TERMINATED
Last Update Posted:
2025-01-09
First Post:
2018-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing and Validating Fertilit-e
Sponsor:
Organization:
Raw JSON
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Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.\n\nQuestionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of Fertilit-e Alpha - Usability (Number of Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fertilit-e', 'description': 'Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.\n\nInterview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.\n\nQuestionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.'}], 'classes': [{'title': 'Homepage', 'categories': [{'title': 'Usable', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not usable', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Risks/Options', 'categories': [{'title': 'Usable', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not usable', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Personal Stories', 'categories': [{'title': 'Usable', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not usable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Financial Concerns', 'categories': [{'title': 'Usable', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Not usable', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FAQ', 'categories': [{'title': 'Usable', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not usable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Personal Summary', 'categories': [{'title': 'Usable', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not usable', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'To evaluate Fertilit-e alpha, we will examine its usability through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Evaluation of Fertilit-e Alpha- Usability (System Usability Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fertilit-e', 'description': 'Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.\n\nInterview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.\n\nQuestionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.0', 'spread': '15.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'To evaluate Fertilit-e alpha, we will examine its usability through the System Usability Scale, a simple, ten-item attitude Likert scale (1 - strongly disagree to 5 strongly agree) giving a global view of subjective assessments of usability. The score range is 0 to 100. Higher scores are better and scores above 68 are considered above average.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of Fertilit-e Alpha- Comprehensibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fertilit-e', 'description': 'Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.\n\nInterview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.\n\nQuestionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.'}], 'classes': [{'title': 'Homepage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Comprehensible', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Not comprehensible', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Risks/Options', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Comprehensible', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not comprehensible', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Personal Stories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Comprehensible', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not comprehensible', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Financial Concerns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Comprehensible', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not comprehensible', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'FAQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Comprehensible', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not comprehensible', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Personal Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Comprehensible', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not comprehensible', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'To evaluate Fertilit-e alpha, we will examine its comprehensibility and design through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 12 participants for Personal Stories, FAQ, and Personal Summary did not provide data for these themes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fertilit-e', 'description': 'Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.\n\nInterview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.\n\nQuestionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fertilit-e', 'description': 'Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.\n\nInterview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.\n\nQuestionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '21 participants were enrolled/consented. Nine participants were lost to follow up and no data was collected. Only 12 participants have data that was collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-30', 'size': 730310, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-19T15:17', 'hasProtocol': True}, {'date': '2023-05-25', 'size': 177182, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-19T15:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI decision - competing study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2018-07-13', 'resultsFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-20', 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Fertilit-e Alpha - Usability (Number of Participants)', 'timeFrame': '6 months', 'description': 'To evaluate Fertilit-e alpha, we will examine its usability through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.'}, {'measure': 'Evaluation of Fertilit-e Alpha- Usability (System Usability Scale)', 'timeFrame': '6 months', 'description': 'To evaluate Fertilit-e alpha, we will examine its usability through the System Usability Scale, a simple, ten-item attitude Likert scale (1 - strongly disagree to 5 strongly agree) giving a global view of subjective assessments of usability. The score range is 0 to 100. Higher scores are better and scores above 68 are considered above average.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Fertilit-e Alpha- Comprehensibility', 'timeFrame': '6 months', 'description': 'To evaluate Fertilit-e alpha, we will examine its comprehensibility and design through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Fertility', 'Preservation'], 'conditions': ['Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'The main purpose of this project is to adapt and validate an eHealth fertility preservation decision-making support tool (Fertilit-e) for young adults with cancer.', 'detailedDescription': "The overarching goal is to utilize innovations in eHealth technology to address fertility preservation knowledge deficits and decision-making options for young adults with cancer ages 18-39 years of age. Every year, approximately 70,000 young adults (ages 18-39) are diagnosed with cancer, which can significantly affect their health-related quality of life in multiple areas, including the potential for infertility or other reproductive challenges. Despite this, very few young adults diagnosed with cancer are actually provided fertility preservation information let alone effective strategies or tools for how to best navigate their fertility preservation options. It is critical to provide decision-making information and support about infertility risk and existing interventions to maintain reproductive potential in a delivery mode that is most congruent with this population's health communication style, such as eHealth applications.\n\nThe goal is to adapt and optimize fertility preservation content in a tailored mHealth tool for fertility preservation decision-making. More specifically, the team will adapt fertility-preservation content for tailored, rapid, and clear dissemination of information in an engaging, cross-platform, patient-friendly mHealth format. The study team will alpha-test this tool with an ethnically diverse sample of cross-cultural end users to collect qualitative data and evaluate usability and comprehensibility to refine content and design. No formal hypothesis testing will be done."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young adults with cancer who are currently ages 18 to 39.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of cancer during ages 15 to 39.\n* Will be receiving or have received treatment associated with a risk of infertility (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery with potential impact on reproductive function).\n* Considered or wish they had considered fertility preservation treatments.\n* Able to speak, read, and understand English.\n* Able to provide informed consent.\n* Have internet access.\n* Have a laptop or desktop computer that can connect to WebEx.\n\nExclusion Criteria:\n\n* Infertility diagnosis prior to cancer diagnosis.\n* History of fertility preservation or fertility treatments prior to their cancer diagnosis.\n* Are more than five years post-cancer-related treatments (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery).'}, 'identificationModule': {'nctId': 'NCT03599661', 'briefTitle': 'Developing and Validating Fertilit-e', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Developing and Validating Fertilit-e: An eHealth Fertility Preservation Decision Aid for Young Adults With Cancer - Aim 1', 'orgStudyIdInfo': {'id': 'IRB00047585'}, 'secondaryIdInfos': [{'id': 'CCCWFU 01717', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fertilit-e', 'description': 'Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.', 'interventionNames': ['Other: Interview', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.', 'armGroupLabels': ['Fertilit-e']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.', 'armGroupLabels': ['Fertilit-e']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'John Salsman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}