NCT01432132

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Longer than 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

August 24, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

5.9 years

First QC Date

September 8, 2011

Last Update Submit

August 3, 2017

Conditions

Keywords

Head and Neck CancerBody Image AdaptationPost surgical body imageAudio-recorded interviewQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Patients' Body Image Adaptation (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.

    Study period 2 years to complete face-to-face interviews

Study Arms (2)

Head & Neck Patients

Patients undergoing surgical treatment for head and neck cancer.

Behavioral: InterviewBehavioral: Questionnaire

Clinicians

Clinical staff who care for head and neck surgical participants during active treatment.

Behavioral: Interview

Interventions

InterviewBEHAVIORAL

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

CliniciansHead & Neck Patients
QuestionnaireBEHAVIORAL

Questionnaire about demographic information such as age and ethnicity.

Also known as: Survey
Head & Neck Patients

Eligibility Criteria

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

Participants will be drawn from the Head and Neck Center at MD Anderson Cancer Center in Houston, Texas

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

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
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 12, 2011

Study Start

August 24, 2011

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations