Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04066218
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2019-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sexual Function Screening in Childhood Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2019-08-21', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe AYA CCS perspectives on implementation of screening for sexual dysfunction, including preferred modality, setting and timing for evaluating sexual dysfunction.', 'timeFrame': '1 year', 'description': 'Qualitative interviews will be conducted by phone by a trained qualitative research interviewer. Interviews will be in-depth and semistructured, utilizing a combination of broad, open-ended questions and more specific probes. The interview guide was developed with the help of Dr. Michael Fisher, PhD, who has expertise in qualitative research methodology. The interviewer will take detailed field notes. This portion of the interview will last approximately 25-35 minutes and will be digitally recorded and professionally transcribed. After each interview, the interviewer will complete an Interview Summary Form, which will serve as a memoing tool and summarize initial themes or impressions that may be relevant to the research question.'}], 'secondaryOutcomes': [{'measure': 'Assess AYA CCS perceptions of the PROMIS SexFS Brief, an existing adult clinical screening tool for sexual dysfunction, in a qualitative pilot study.', 'timeFrame': '1 year', 'description': 'Participants will be asked to evaluate the PROMIS SexFS Brief, which will be emailed to them at the time of the interview via a unique/secure REDCap link. Participants will be given a choice of which version of the tool they complete (male or female). Participants will be asked to complete the PROMIS SexFS Brief via REDCap while completing Think-Aloud methodology. Via Think-Aloud, participants will be asked to verbalize their thoughts as they proceed through the task, which asks participants to verbalize their thoughts, without probing or additional explanations, as they undertake a task such as completing a clinical screening questionnaire. In accordance with recommendations for conducting Think-Aloud, participants will participate in a warm-up exercise unrelated to sexual dysfunction prior to completing Think-Aloud.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Cancer', 'Survivorship', 'Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a qualitative research study involving semistructured interviews and Think-Aloud methodology during completion of a clinical screening tool. All participants will undergo the same semistructured interviews.', 'detailedDescription': 'The proposed research will explore patient-centered approaches to evaluating younger Adolescent/young adult Childhood cancer survivors for sexual dysfunction, including strategies for implementation and usability of thePatient-Reported Outcomes Measurement Information® v2.0 Brief Profile for Sexual Function and Satisfaction Brief, an existing adult screening tool. This study will include interviews with 24 patients age 15-24 who were diagnosed with cancer prior to age 18, and treated with chemotherapy, radiation and/or surgery and are now at least two years off therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "* Sample size\n\n * Max number of participants that can be enrolled is 30\n * Max number of participants that can be interviewed is 24\n* Gender Male and Female\n* Age Range 15-24\n* Demographic group English-speaking\n* General health status Pediatric cancer survivors (diagnosed at \\<18 years of age and now at least 2 years off therapy)\n* Geographic location Children's Hospital Colorado and University of Colorado Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to read and understand the postcard consent.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Age 15-24 at time of enrollment\n4. History of cancer diagnosis, diagnosed at \\<18 years old\n5. Off therapy (chemotherapy, surgery, radiation) for a minimum of 2 years\n6. Sufficient cognitive functioning such that participants are able to complete study measures, as determined by their physician and research personnel.\n\nExclusion Criteria:\n\n1. Developmental or intellectual disability, as determined by the patient's physician\n2. Received neither chemotherapy nor radiation therapy\n3. Non-English speaking\n4. Non-English reading"}, 'identificationModule': {'nctId': 'NCT04066218', 'briefTitle': 'Sexual Function Screening in Childhood Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer', 'orgStudyIdInfo': {'id': '19-1111.cc'}, 'secondaryIdInfos': [{'id': 'P30CA046934', 'link': 'https://reporter.nih.gov/quickSearch/P30CA046934', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'age 15-19', 'description': 'The investigators plan to complete 24 interviews with 12 in the age 15-19 cohort.The investigators will also ensure that at least 8 people from each sex are included in this study.', 'interventionNames': ['Other: Interviews']}, {'label': 'age 20-24', 'description': 'The investigators plan to complete 24 interviews with 12 in the age 20-24 cohort. The investigators will also ensure that at least 8 people from each sex are included in this study.', 'interventionNames': ['Other: Interviews']}], 'interventions': [{'name': 'Interviews', 'type': 'OTHER', 'description': '* Participation will serve as verbal consent.\n* Qualitative PRA will call participant to schedule either phone or in person interview. If via phone, the study PRA performing the interview, will remind them to find a private space to speak.\n* REDCap link will be sent for PROMIS SexFS Brief.\n* PRA will perform semistructured interview and guide Think-Aloud to complete the PROMIS SexFS Brief.\n* Participants will not submit responses to PROMIS SexFS Brief responses after completing the tool.', 'armGroupLabels': ['age 15-19', 'age 20-24']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado School of Public Health, University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}