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Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01432132
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Head and Neck Cancer Behavioral: Interview Behavioral: Questionnaire

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer
Actual Study Start Date : August 24, 2011
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : July 25, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Head & Neck Patients
Patients undergoing surgical treatment for head and neck cancer.
Behavioral: Interview
Face-to-face audio recorded interview. It should take about 1 hour to complete.
Behavioral: Questionnaire
Questionnaire about demographic information such as age and ethnicity.
Other Name: Survey
Clinicians
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.



Primary Outcome Measures :
  1. Patients' Body Image Adaptation (Interviews) [ Time Frame: Study period 2 years to complete face-to-face 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be drawn from the Head and Neck Center at MD Anderson Cancer Center in Houston, Texas
Criteria

Inclusion Criteria:

  1. At least 18 years of age
  2. English speaking
  3. 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.
  4. 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.
  5. For providers: Having worked with surgically treated head and neck cancer patients for at least one year.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432132


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michelle C. Fingeret, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01432132     History of Changes
Other Study ID Numbers: 2011-0558
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Body Image Adaptation
Post surgical body image
Audio-recorded interview
Questionnaire
Survey

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms