Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT01606293
Status:
UNKNOWN
Last Update Posted:
2019-12-20
First Post:
2012-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2012-05-23', 'studyFirstSubmitQcDate': '2012-05-24', 'lastUpdatePostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Using Social Networking Groups to Survey Patients with Rare Cancers.', 'timeFrame': '1 day', 'description': 'The entire study will be conducted electronically. A survey assessing presentation of disease, treatment history and follow-up will be hosted on a secured online server. In addition respondents will be asked to complete a battery of 40 questions assessing anxiety regarding their diagnosis and fear of recurrence based on previously published instruments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small cell carcinomas of the cervix', 'Large cell carcinomas of the cervix', 'Online surveys', 'Electronic surveys', 'Questionnaires', 'Facebook', 'Social networking support groups'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nPrimary: 1. To assess the feasibility of using social networking groups to survey patients with rare cancers.\n\nSecondary:1. To elucidate the current means for diagnosis and treatment of women with small and large cell carcinomas of the cervix. 2. To evaluate anxiety regarding diagnosis, treatment, and recurrence among women with small and large cell carcinomas of the cervix.', 'detailedDescription': 'The entire study will be conducted electronically. A survey assessing presentation of disease, treatment history and follow-up (appendix A) will be hosted on a secured online server. In addition respondents will be asked to complete a battery of 40 questions assessing anxiety regarding their diagnosis and fear of recurrence based on previously published instruments (appendix B).\n\nPatients will be asked to provide data on the presenting symptoms at the time of the diagnosis, method of diagnosis, HPV detection, modalities used as initial treatment, specialty of the physician administering the treatment, stage, follow up interval and diagnostic studies, recurrence free interval and treatments offered/received at the time of recurrence.\n\nTo assess anxiety and fear of recurrence we will be using questions from instruments initially used in a breast cancer population:\n\nThe Concerns About Recurrence Scale (CARS): The CARS has two main parts. In the first part, overall fear of recurrence is assessed with four questions addressing frequency, potential for upset, consistency, and intensity of fears. Participants rate each of these items on a 1-to-6 scale. In the second part, the nature of women\'s fears about recurrence is assessed with 26 items that follow the stem phrase: "I worry that a recurrence of cancer would" Participants use a 5-pointscale, ranging from 0 (not at all), to 1 (a little), to 2 (moderately), to 3 (a lot), and to 4 (extremely), to indicate the extent to which they worry about each item.\n\nLerman Cancer Worry Scale: This includes three items, one measuring the frequency of worrying about "getting recurrence cancer someday," and two items measuring the impact of worry on mood and performing daily activities. For cancer worry, subjects will rate their current levels of worry about getting cancer recurrence someday on a 5-point scale with points labeled not at all (1), rarely (2), sometimes (3), often (4), and almost all the time (5). For impact of worry on mood and on functioning, respondents experiencing cancer worries will rate the current impact of such worries on their moods and on their ability to perform their daily activities using a 4-point scale with points labeled not at all (I),a little (2), somewhat (3), and a lot (4).\n\nThe Survey will be offered to all patients who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link. We expect the survey to take participants 15-20 minutes to complete. Surveys with similar anxiety measuring elements conducted by phone and on the internet have been reported with success.\n\nPatients will be presented with an online informed consent prior to taking the survey. In addition patients will be provided with an email address and a phone number to use if they have any questions or wish to withdraw from the study. Upon reading the informed consent patients will be able to proceed to the questionnaire hence signifying their informed consent or back to Facebook indicating their refusal. No personal identifying data will be collected. Prior to taking the survey they will be given a serial number to associate with their answers in case they wish to withdraw in the future.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with small cell carcinoma of the cervix who are members of a social networking support group on Facebook who give informed consent and are able to complete a 15 min online survey.\n\nExclusion Criteria:\n\n* Women with small cell carcinoma of the cervix who are members of a social networking support group on Facebook who cannot respond to an English online survey.'}, 'identificationModule': {'nctId': 'NCT01606293', 'briefTitle': 'Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix', 'orgStudyIdInfo': {'id': '2012-0464'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carcinomas of the Cervix Survey', 'description': 'Women with small and large cell carcinomas of the cervix, who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link.', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Electronic surveys'], 'description': 'Completion of online surveys taking approximately 15 - 20 minutes.', 'armGroupLabels': ['Carcinomas of the Cervix Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Michael M. Frumovitz, MD, MPH', 'role': 'CONTACT', 'phone': '713-792-9599'}], 'overallOfficials': [{'name': 'Michael M. Frumovitz, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}