Mirror Grant - Understanding of Body Image Adaptation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01432132
First received: September 8, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.

Specific Aims:

  1. To examine patients' experiences of viewing themselves in the mirror immediately after surgical treatment for head and neck cancer, during active treatment and into survivorship.
  2. To examine clinicians' and other staffs' observations of patients viewing themselves in the mirror following disfiguring surgery.
  3. To identify interactions and processes, including mirror viewing and reactions of others, by which patients who have had surgery for head and neck cancers understand their appearance changes and feel about their body image.

Condition Intervention
Head and Neck Cancer
Behavioral: Interview
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patients' Body Image Adaptation (Interviews) [ Time Frame: Study period 2 years to complete face-to-face interviews ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 35
Study Start Date: August 2011
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432132

Contacts
Contact: Michelle C. Fingeret, PHD 713-794-1247

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
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
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01432132     History of Changes
Other Study ID Numbers: 2011-0558
Study First Received: September 8, 2011
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

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
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014