An observational study in Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.
Sponsored by M.D. Anderson Cancer Center · Observational
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.
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.
The 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.
If 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.
Identifying 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.
This is an investigational study.
Up to 20 patients and 15 healthcare providers will take part in this study. All will be enrolled at MD Anderson.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 25 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be drawn from the Head and Neck Center at MD Anderson Cancer Center in Houston, Texas
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1) For patients: cognitive impairment documented in their medical record (e.g. delirium, dementia) impeding the ability to offer a narrative of his/her experience.
Patients undergoing surgical treatment for head and neck cancer.
Behavioral: Interview · Behavioral: Questionnaire
Clinical staff who care for head and neck surgical participants during active treatment.
Behavioral: Interview
Face-to-face audio recorded interview. It should take about 1 hour to complete.
Questionnaire about demographic information such as age and ethnicity.
Also known as: Survey
Patients' Body Image Adaptation (Interviews)
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.
Time frame: Study period 2 years to complete face-to-face interviews
Ran from Aug 2011 to primary completion in Jul 2017, 71 months.
Of 193 non-industry observational studies under Head and Neck Neoplasms, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 158. This study's 71 months is below that.
Counting every sponsor, half of 211 studies reached it within 77 months; a quarter within 35 and three quarters within 158.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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