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Completed

NCT Number: NCT01432132

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • For patients: cognitive impairment documented in their medical record (e.g. delirium, dementia) impeding the ability to offer a narrative of his/her experience.

Treatment and study plan

Interview

Behavioral

Face-to-face audio recorded interview. It should take about 1 hour to complete.

Questionnaire

Behavioral

Questionnaire about demographic information such as age and ethnicity.

Other names: Survey

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2011
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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