Oral Cavity CancerNCT00412490
Smoking Status and Body Image in Oral Cancer Patients
An observational study of Oral Cavity Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures. 2. To examine the relationship between smoking status and body image in this sample of head and neck cancer patients. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Cancer
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2014
- 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: Individuals, age 18 years or older, diagnosed with head and neck malignancy involving an oral cavity site without previous treatment, and current treatment plan includes surgical intervention.
Who may be able to join
- 18 years of age or older
- Able to provide written informed consent to participate
- Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
- Current treatment plan includes surgical intervention
- English speaking
Who cannot join
- Previous treatment for malignancy in the head and neck region
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity
Primary Objectives:
- To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
- To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
- To examine the influence of smoking status and body image on quality of life outcomes.
Read the detailed description
If you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (CO) in your blood. To do this test, you will be asked to blow into a cardboard tube attached to a machine. You will then be asked to fill out some questionnaires and complete a one-on-one interview. All of these things combined will take about an hour to complete. You will be asked basic questions such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and how you feel about your appearance.
If you do not have surgery, your participation in this study will end after this visit. If you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. During these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. Each visit will last about an hour. You will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. Your participation in this study will be finished after the 6-month evaluation.
This is an investigational study. About 75 people will take part in this research study. All will be enrolled at M. D. Anderson.
- Conditions
- Oral Cavity Cancer
- Being tested
- Questionnaire, Interview
- Keywords
- Oral Cavity Cancer, Body Image, Smoking, Appearance, Questionnaire, Interview
- Medical subject headings
- Mouth Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Written survey at 1 Month \& 6 Months post surgery.
InterviewBehavioural
One-on-One meeting lasting about one hour, at 1 Month \& 6 Months post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Behavior Group | Individuals Having Surgery for Oral Cavity Cancer. Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.
Preliminary analyses involve two-sample t-tests of difference in body image between male and female, one-way ANOVA to compare body image across ethnicity groups, and calculation of Pearson product moment correlation coefficients between body image and age.
Measured: Baseline, 1 Month and 6 Months Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity 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
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen R. Gritz, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412490
- Sponsor's protocol ID
- 2005-0126
- Other IDs
- 5R25CA057730-11
- Status last verified
- Jan 2016
- First submitted
- 15 Dec 2006
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity
- ClinicalTrials.gov ID
- NCT00412490
- Acronym / sponsor ID
- 2005-0126
- Conditions
- Oral Cavity Cancer
- Keywords
- Oral Cavity Cancer, Body Image, Smoking, Appearance, Questionnaire, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Dec 2006 (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.
Primary Objectives:
- To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
- To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
- To examine the influence of smoking status and body image on quality of life outcomes.
Detailed description
If you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (CO) in your blood. To do this test, you will be asked to blow into a cardboard tube attached to a machine. You will then be asked to fill out some questionnaires and complete a one-on-one interview. All of these things combined will take about an hour to complete. You will be asked basic questions such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and how you feel about your appearance.
If you do not have surgery, your participation in this study will end after this visit. If you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. During these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. Each visit will last about an hour. You will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. Your participation in this study will be finished after the 6-month evaluation.
This is an investigational study. About 75 people will take part in this research study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Behavior Group | – | Behavioral: Questionnaire, Behavioral: InterviewIndividuals Having Surgery for Oral Cavity Cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals, age 18 years or older, diagnosed with head and neck malignancy involving an oral cavity site without previous treatment, and current treatment plan includes surgical intervention.
Key inclusion criteria (5 listed)
- 18 years of age or older
- Able to provide written informed consent to participate
- Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
- Current treatment plan includes surgical intervention
- English speaking
Key exclusion criteria (3 listed)
- Previous treatment for malignancy in the head and neck region
- 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.
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 |
|---|---|---|
| QuestionnaireWritten survey at 1 Month \& 6 Months post surgery. | Behavioural | Smoking Behavior Group |
| InterviewOne-on-One meeting lasting about one hour, at 1 Month \& 6 Months post surgery. | Behavioural | Smoking Behavior Group |
Primary outcome
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.
Time frame: Baseline, 1 Month and 6 Months Post Surgery
Preliminary analyses involve two-sample t-tests of difference in body image between male and female, one-way ANOVA to compare body image across ethnicity groups, and calculation of Pearson product moment correlation coefficients between body image and age.
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 29 Jan 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Oral Cavity Cancer
RecruitingPhase 1/2
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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Active, not recruitingPhase 1/2
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RecruitingPhase 1/2
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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.
Ellen R. Gritz, 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 Oral Cavity 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 29 Jan 2016. 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?
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors. (time frame: Baseline, 1 Month and 6 Months Post Surgery). 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 29 Jan 2016.