Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 4:23 AM
Study NCT ID:
NCT04363957
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2020-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gynecologic Brachytherapy-Specific Educational Video
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CancerCTO@health.ucsd.edu', 'phone': '(858) 822-5354', 'title': 'Dr. Jyoti Mayadev', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 11 months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Consent', 'description': 'Patients only receive the standard brachytherapy consent process\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Consent and Video Intervention', 'description': 'Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy\n\nBrachytherapy video: Patients will watch a video that contains information about brachytherapy\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Reported Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Consent', 'description': 'Patients only receive the standard brachytherapy consent process\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}, {'id': 'OG001', 'title': 'Standard Consent and Video Intervention', 'description': 'Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy\n\nBrachytherapy video: Patients will watch a video that contains information about brachytherapy\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '54'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Primary Analysis based on Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale study specific questionnaire (no unabbreviated scale title, Likert-scale is a general untitled tool) is used to calculate satisfaction score.\n\nUsing the brachytherapy specific questionnaire, the study team will examine three patient reported time points for impact: baseline, after the consent process, and prior to the last brachytherapy procedure. For primary endpoint, a two-sample t-test will be used to compare differences of satisfaction scores at two time points (baseline and following consent process) between groups. The reporting scale is the following:\n\nStrongly disagree (1); Disagree (2); Uncertain (3); Agree (4); Strongly agree (5)\n\nMinimum: 1; Maximum: 5.\n\nQuestionnaire had 12 questions. Minimum possible score is 12; Maximum possible score is 60. Higher score means higher satisfaction.', 'unitOfMeasure': 'satisfaction score at baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Related Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Consent', 'description': 'Patients only receive the standard brachytherapy consent process\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}, {'id': 'OG001', 'title': 'Standard Consent and Video Intervention', 'description': 'Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy\n\nBrachytherapy video: Patients will watch a video that contains information about brachytherapy\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Satisfactory scores at three time points will be analyzed using a mixed effect model for repeated measures (MMRM) to assess satisfactory scores trajectories between two arms. The MMRM model will include terms for time, consent arm, baseline score, arm-by-time interaction, baseline score by time interaction, plus covariates that include age, stage. Time will be treated as categorical. If values of last two time points are similar, analysis of covariance model (ANCOVA) will be used to model the change in satisfactory scores. The mean of the last two time points will be calculated. That is, the after consent score (mean values) will be regressed upon baseline score and consent arms. Patient treatment-related anxiety between groups, defined as National Comprehensive Cancer Network (NCCN) distress score, are also collected at three time points and will be analyzed using the same strategy. The NCCN distress scale is from 0 (min) -10 (max) with 10 being a value that is more distress- worse.', 'unitOfMeasure': 'anxiety score at baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Consent', 'description': 'Patients only receive the standard brachytherapy consent process\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}, {'id': 'FG001', 'title': 'Standard Consent and Video Intervention', 'description': 'Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy\n\nBrachytherapy video: Patients will watch a video that contains information about brachytherapy\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Consent', 'description': 'Patients only receive the standard brachytherapy consent process\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}, {'id': 'BG001', 'title': 'Standard Consent and Video Intervention', 'description': 'Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy\n\nBrachytherapy video: Patients will watch a video that contains information about brachytherapy\n\nStandard Brachytherapy Consent Process: Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '88'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '89'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Cancer', 'classes': [{'categories': [{'title': 'Cervix', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Uterine', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Vagina', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-18', 'size': 591061, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-09T18:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this open-label study design, eligible participants will be randomized using a simple 1:1 schedule to either brachytherapy verbal standard consent (Arm A), or the brachytherapy specific video (Arm B), based on chronological arrival in clinic'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2020-04-03', 'resultsFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-22', 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Reported Satisfaction', 'timeFrame': 'Baseline', 'description': 'Primary Analysis based on Intention-to-Treat population, defined as all individuals who were randomized to arm A or arm B. A Likert-scale study specific questionnaire (no unabbreviated scale title, Likert-scale is a general untitled tool) is used to calculate satisfaction score.\n\nUsing the brachytherapy specific questionnaire, the study team will examine three patient reported time points for impact: baseline, after the consent process, and prior to the last brachytherapy procedure. For primary endpoint, a two-sample t-test will be used to compare differences of satisfaction scores at two time points (baseline and following consent process) between groups. The reporting scale is the following:\n\nStrongly disagree (1); Disagree (2); Uncertain (3); Agree (4); Strongly agree (5)\n\nMinimum: 1; Maximum: 5.\n\nQuestionnaire had 12 questions. Minimum possible score is 12; Maximum possible score is 60. Higher score means higher satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Treatment Related Anxiety', 'timeFrame': 'Baseline', 'description': 'Satisfactory scores at three time points will be analyzed using a mixed effect model for repeated measures (MMRM) to assess satisfactory scores trajectories between two arms. The MMRM model will include terms for time, consent arm, baseline score, arm-by-time interaction, baseline score by time interaction, plus covariates that include age, stage. Time will be treated as categorical. If values of last two time points are similar, analysis of covariance model (ANCOVA) will be used to model the change in satisfactory scores. The mean of the last two time points will be calculated. That is, the after consent score (mean values) will be regressed upon baseline score and consent arms. Patient treatment-related anxiety between groups, defined as National Comprehensive Cancer Network (NCCN) distress score, are also collected at three time points and will be analyzed using the same strategy. The NCCN distress scale is from 0 (min) -10 (max) with 10 being a value that is more distress- worse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Uterine Cancer']}, 'referencesModule': {'references': [{'pmid': '37247940', 'type': 'DERIVED', 'citation': 'Kotha NV, Guram K, Morgan K, Deshler L, Brown D, Rash D, Dyer B, McHale M, Yashar C, Scanderbeg D, Einck J, Mayadev J. A randomized patient education trial investigating treatment-related distress and satisfaction with the use of an at-home gynecologic brachytherapy educational video. Int J Gynecol Cancer. 2023 Jul 3;33(7):1125-1131. doi: 10.1136/ijgc-2023-004331.'}]}, 'descriptionModule': {'briefSummary': 'Brachytherapy is a highly technical and integral component of the definitive treatment of gynecologic cancers \\[1\\]. To enhance provider communication and patient engagement, our study investigates a video consent on impact of patient treatment-related outcomes.\n\nThe study team will use a detailed brachytherapy video in addition to the standard brachytherapy verbal consent to evaluate patient-reported satisfaction and patient anxiety for gynecologic high-dose rate brachytherapy (a radiation procedure).', 'detailedDescription': '1:1 randomized trial using blocked randomization based on chronologic arrival in clinic, a group of patients will be randomized to the standard of care verbal consent (Arm A), or the standard of care consent plus the online brachytherapy informed video consent (Arm B). There will be three time points for the collection: After the standard consent process as the baseline, following the standard only vs standard and educational video consent process prior to the first brachytherapy procedure, and prior to the last brachytherapy procedure. The patients in the brachytherapy video consent process will be watching this online. The patient will be given a specific log in to use, and study researchers will be able to track the number of times the patient watches the video and the completion of the video view. The patient is allowed to watch the video as many times as desired'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient has the ability to understand and the willingness to sign a written informed consent.\n2. Patient must be female, all races and ethnic groups are eligible.\n3. Must be \\> 18 years of age, or have parental approval for inclusion.\n4. Must carry a diagnosis of gynecologic malignancy.\n5. Is deemed to require high-dose rate gynecologic brachytherapy procedure (intracavitary, hybrid intracavitary/interstitial, or interstitial).\n6. Any prior external beam radiation therapy is allowed.\n7. Any performance status is allowed.\n8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for # days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n * Has not undergone a hysterectomy or bilateral oophorectomy; or\n * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n\nExclusion Criteria:\n\n* 1\\. Patient has had prior high-dose rate gynecologic brachytherapy at any point in the past.\n\n 2\\. . Patient is a non English speaker\n\n 3\\. Patient is unable to watch the video\n\n 4\\. Patient declines consent to the study\n\n 5\\. Study-specific exclusion criteria.\n\n 6\\. Patient has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)."}, 'identificationModule': {'nctId': 'NCT04363957', 'briefTitle': 'Gynecologic Brachytherapy-Specific Educational Video', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video', 'orgStudyIdInfo': {'id': '181519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Consent', 'description': 'Patients only receive the standard brachytherapy consent process', 'interventionNames': ['Other: Standard Brachytherapy Consent Process']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Consent and Video Intervention', 'description': 'Patients receive the standard brachytherapy consent process and the addition of an informational video about brachytherapy', 'interventionNames': ['Other: Brachytherapy video', 'Other: Standard Brachytherapy Consent Process']}], 'interventions': [{'name': 'Brachytherapy video', 'type': 'OTHER', 'description': 'Patients will watch a video that contains information about brachytherapy', 'armGroupLabels': ['Standard Consent and Video Intervention']}, {'name': 'Standard Brachytherapy Consent Process', 'type': 'OTHER', 'description': 'Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.', 'armGroupLabels': ['Standard Consent', 'Standard Consent and Video Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UC San Diego Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Jyoti Mayadev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Jyoti Mayadev, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}