Head and Neck CancerNCT00824174
Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer
An observational study of Head and Neck Cancer and Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Skin Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, 18 years or older, with oral cavity or cutaneous cancer receiving surgical treatment.
Who may be able to join
- 18 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Primary Aims
- 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.
- 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.
Secondary Aim
- To compare body image and quality of life outcomes for patients with oral cavity, cutaneous, and midface cancers.
Read the detailed description
If you agree to take part in this study, you will be asked to fill out 1 questionnaire. This questionnaire can be filled out while you are waiting to be seen by your head and neck doctor and will take about 15-20 minutes to complete.
In this questionnaire, you will be asked questions such as your age, gender, education level, and smoking history. You will also be asked about your treatment for cancer and how it has affected your appearance and body. There will also be questions about your mood, physical health, alcohol use, and social well-being.
Length of Study:
You will be off study after you complete the questionnaire.
This is an investigational study. Up to 350 people will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Head and Neck Cancer, Skin Cancer
- Being tested
- Questionnaire
- Keywords
- Questionnaire, Head and Neck Cancer, Skin Cancer, Body Image, Surgical Treatment, Oral Cavity Cancer, Cutaneous Cancer
- Medical subject headings
- Head and Neck Neoplasms, Skin Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
1 questionnaire, about 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | 1 questionnaire, about 15-20 minutes. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body image outcomes (i.e., Body Image Scale) for patients at different time points relative to initiation of treatment
Measured: Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle C Fingeret, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824174
- Sponsor's protocol ID
- 2008-0080
- Status last verified
- Oct 2012
- First submitted
- 15 Jan 2009
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00824174
- Acronym / sponsor ID
- 2008-0080
- Conditions
- Head and Neck Cancer, Skin Cancer
- Keywords
- Questionnaire, Head and Neck Cancer, Skin Cancer, Body Image, Surgical Treatment, Oral Cavity Cancer, Cutaneous Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2012 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Secondary Aim
- To compare body image and quality of life outcomes for patients with oral cavity, cutaneous, and midface cancers.
Detailed description
If you agree to take part in this study, you will be asked to fill out 1 questionnaire. This questionnaire can be filled out while you are waiting to be seen by your head and neck doctor and will take about 15-20 minutes to complete.
In this questionnaire, you will be asked questions such as your age, gender, education level, and smoking history. You will also be asked about your treatment for cancer and how it has affected your appearance and body. There will also be questions about your mood, physical health, alcohol use, and social well-being.
Length of Study:
You will be off study after you complete the questionnaire.
This is an investigational study. Up to 350 people will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: Questionnaire1 questionnaire, about 15-20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, 18 years or older, with oral cavity or cutaneous cancer receiving surgical treatment.
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: Survey1 questionnaire, about 15-20 minutes. | Behavioural | Questionnaire |
Primary outcome
Body image outcomes (i.e., Body Image Scale) for patients at different time points relative to initiation of treatment
Time frame: Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle C Fingeret, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body image outcomes (i.e., Body Image Scale) for patients at different time points relative to initiation of treatment (time frame: Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.