NCT00824174

Brief Summary

Objectives: The purpose of this study is to obtain descriptive information about the nature and extent of body image concerns among surgical patients with head and neck cancer, satisfaction with care received regarding body image issues, and interest in psychosocial services targeting body image disturbance. Findings from this study provide important preliminary data to guide future large scale research on the critical, yet understudied, psychosocial issue of body image functioning for head and neck cancer patients. Information obtained from this study can specifically be used to facilitate the development of appropriate disease-specific body image instruments and to determine the need for body image focused psychosocial interventions to enhance quality of life and the survivorship experience for these patients. Primary Aims

  1. 1.To characterize the nature and extent of body image concerns in surgically treated patients with head and neck cancer and determine preferences for psychosocial intervention.
  2. 2.To compare body image and quality of life outcomes for patients at different time points relative to initiation of treatment. Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

January 15, 2009

Last Update Submit

October 1, 2012

Conditions

Keywords

QuestionnaireHead and Neck CancerSkin CancerBody ImageSurgical TreatmentOral Cavity CancerCutaneous Cancer

Outcome Measures

Primary Outcomes (1)

  • Body image outcomes (i.e., Body Image Scale) for patients at different time points relative to initiation of treatment

    Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment

Study Arms (1)

Questionnaire

1 questionnaire, about 15-20 minutes.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

1 questionnaire, about 15-20 minutes.

Also known as: Survey
Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients, 18 years or older, with oral cavity or cutaneous cancer receiving surgical treatment.

You may qualify if:

  • years of age or older
  • Able to provide written informed consent to participate
  • Diagnosis of oral cavity, cutaneous or other midface cancer involving the head and neck region
  • Treatment plan includes surgical intervention
  • English speaking

You may not qualify if:

  • Significant preexisting facial disfigurement from a previous trauma or congenital defect
  • Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
  • Cognitive impairment (e.g., dementia, delirium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsSkin NeoplasmsMouth Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michelle C Fingeret, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

December 1, 2008

Primary Completion

September 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations