Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-18 @ 7:20 AM
Study NCT ID:
NCT01432132
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2011-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'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': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2011-09-08', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' Body Image Adaptation (Interviews)", 'timeFrame': 'Study period 2 years to complete face-to-face interviews', 'description': "Patients' experiences of viewing themselves in the mirror immediately after surgical treatment for head and neck cancer. Descriptive information derived from 1 hour face-to-face interviews with qualitative methodology using Grounded Theory design and methods with use of constant comparative technique and analysis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Head and Neck Cancer', 'Body Image Adaptation', 'Post surgical body image', 'Audio-recorded interview', 'Questionnaire', 'Survey'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to understand how patients adjust to appearance and body image changes after surgery for head and neck cancer.', 'detailedDescription': 'If you agree to take part in this study, you will take part in a face-to-face interview with the study staff. It should take about 1 hour to complete. You will also be asked to complete a questionnaire about your demographic information such as age and ethnicity. The interview will be done in a private research area and will be audio-recorded.\n\nThe researchers are interested in learning more about your experience of adjusting to the changes in your appearance after your surgery for head and neck cancer. You may be asked to look in a mirror and describe what you see.\n\nIf you ask for another interview, or if the interviewer would like your information made more clear, you will be scheduled for a second interview. You will be provided with an early summary of your interview, and you will be able to provide feedback over the phone or in writing on the accuracy of the information and the conclusions.\n\nIdentifying information will be removed from all data collected using participant numbers kept separately from consent forms and shared only among approved research staff. Names and other identifying information will be deleted from transcripts (write-ups of the interviews) after the first review for accuracy. Interview transcripts will be kept in locked file cabinets at MD Anderson for 3 years and can be looked at only by the study chair and staff. Recorded interviews will be destroyed 3 years after the study results are published.\n\nThis is an investigational study.\n\nUp to 20 patients and 15 healthcare providers will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be drawn from the Head and Neck Center at MD Anderson Cancer Center in Houston, Texas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age\n2. English speaking\n3. For patients: Within 6 weeks of undergoing surgical resection for a tumor in the head and neck region, or within 1-3 years from such surgery.\n4. For providers: Inpatient clinical staff (i.e. surgeons, nurses, nursing assistants, physical therapists) who care for surgically treated head and neck cancer patients during acute postoperative recovery, and/or outpatient clinical staff (i.e. nurses, physician assistants) who care for these patients throughout active treatment and into the period of survivorship.\n5. For providers: Having worked with surgically treated head and neck cancer patients for at least one year.\n\nExclusion Criteria:\n\n1\\) For patients: cognitive impairment documented in their medical record (e.g. delirium, dementia) impeding the ability to offer a narrative of his/her experience.'}, 'identificationModule': {'nctId': 'NCT01432132', 'briefTitle': 'Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer', 'orgStudyIdInfo': {'id': '2011-0558'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Head & Neck Patients', 'description': 'Patients undergoing surgical treatment for head and neck cancer.', 'interventionNames': ['Behavioral: Interview', 'Behavioral: Questionnaire']}, {'label': 'Clinicians', 'description': 'Clinical staff who care for head and neck surgical participants during active treatment.', 'interventionNames': ['Behavioral: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'BEHAVIORAL', 'description': 'Face-to-face audio recorded interview. It should take about 1 hour to complete.', 'armGroupLabels': ['Clinicians', 'Head & Neck Patients']}, {'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Questionnaire about demographic information such as age and ethnicity.', 'armGroupLabels': ['Head & Neck Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Michelle C. Fingeret, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}