Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments interview, questionnaire
Sponsor M.D. Anderson Cancer Center
Start date August 2011
End date August 2018
Trial size 35 participants
Trial identifier NCT01432132, 2011-0558

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients undergoing surgical treatment for head and neck cancer.
interview
Face-to-face audio recorded interview. It should take about 1 hour to complete.
questionnaire Survey
Questionnaire about demographic information such as age and ethnicity.
Clinical staff who care for head and neck surgical participants during active treatment.
interview
Face-to-face audio recorded interview. It should take about 1 hour to complete.

Primary Outcomes

Measure
Patients' Body Image Adaptation (Interviews)
time frame: Study period 2 years to complete face-to-face interviews

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer
Principal investigator Michelle C. Fingeret, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.