Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-06 @ 10:21 PM
Study NCT ID:
NCT02058550
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2014-02-06', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation', 'timeFrame': 'Up to 25 months after completing radiation', 'description': 'The vaginal dilator adherence measurements will analyzed in repeated measures model with treatment as a fixed effect and time as a within subject effect. The overall mean of vaginal dilator adherence among the 3 groups will also be measured and compared. The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in.'}], 'secondaryOutcomes': [{'measure': 'Vaginal canal length', 'timeFrame': 'Up to 25 months after completing radiation', 'description': 'The vaginal canal length will be measured using an extra small dilator and it will be calculated in centimeters. The vaginal canal length measurements will be analyzed in a repeated measures model with treatment as a fixed effect and time as a within subject effect. The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in.'}, {'measure': 'Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03', 'timeFrame': 'Up to 30 days after the last dose of study treatment', 'description': "The adverse events will be tabulated by type and grade at each follow up. The total number of AE's as well as the number of AE's in each category: gynecologic, urinary and gastrointestinal will tabulated. The test of proportion will be done per category of AE. Since it is possible that the rates will be low, an exact test will be used to compare the rates."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Endometrial Cancer', 'Radiation Toxicity', 'Vaginal Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluate whether there are differences in the length of vaginal canal between the non-intervention and intervention groups. Evaluate rates of gynecologic, urinary, and gastrointestinal toxicity.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nARM I: Patients receive no additional reminders.\n\nARM II: Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.\n\nARM III: Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up.\n\nAfter completion of study, patients are followed up at 10-14 weeks, 5-7 months, 8-10 months, 11-13 months, 15-17 months, 19-21 months, and 23-25 months post treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment\n* Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment.\n* Patients should have a life expectancy of at least 1 year\n* No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements\n* No organ and marrow function requirements\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded\n* No restrictions regarding use of other investigational agents\n* No exclusion requirements due to co-morbid disease or intercurrent illness\n* No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device\n* No exclusion criteria relating to concomitant medications\n* No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)'}, 'identificationModule': {'nctId': 'NCT02058550', 'briefTitle': 'Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy', 'orgStudyIdInfo': {'id': 'IRB-29074'}, 'secondaryIdInfos': [{'id': 'NCI-2013-02400', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'GYN0005', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm I (no intervention)', 'description': 'Patients receive no additional reminders.'}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (email survey)', 'description': 'Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.', 'interventionNames': ['Other: survey administration', 'Other: computer-assisted intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (email surveys and phone calls)', 'description': 'Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up.', 'interventionNames': ['Other: survey administration', 'Other: computer-assisted intervention', 'Behavioral: telephone-based intervention']}], 'interventions': [{'name': 'survey administration', 'type': 'OTHER', 'description': 'Receive reminder email survey', 'armGroupLabels': ['Arm II (email survey)', 'Arm III (email surveys and phone calls)']}, {'name': 'computer-assisted intervention', 'type': 'OTHER', 'description': 'Receive reminder email survey', 'armGroupLabels': ['Arm II (email survey)', 'Arm III (email surveys and phone calls)']}, {'name': 'telephone-based intervention', 'type': 'BEHAVIORAL', 'description': 'Receive reminder phone call', 'armGroupLabels': ['Arm III (email surveys and phone calls)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Elizabeth Kidd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University Hospitals and Clinics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}