Anxiety DisorderNCT00483639
Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer
An observational study of Anxiety Disorder and Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Anxiety Disorder, Head and Neck Cancer, Lung Cancer
- What is being tested?
- Medical chart review, Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory and management of therapy complications
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2003to Jan 2008
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have been treated for head and neck cancer.
PATIENT CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Head and neck cancer
- Lung cancer (control group)
- Must have received treatment for head and neck cancer or lung cancer within the past 5 years
PATIENT CHARACTERISTICS:
- Able to speak and read English to answer surveys, interviews, and questionnaires
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Social Anxiety and Avoidance in Head and Neck Cancer Patients
RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients.
PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.
Read the detailed description
OBJECTIVES:
- Determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer.
- Determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients.
- Determine the effect of social anxiety and/or avoidance on the quality of life of these patients.
- Investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer.
OUTLINE: This is a cross-sectional study. Patients are stratified according to prior treatment type (significantly impairing [surgery] vs less impairing [chemotherapy/radiotherapy]).
Patients undergo a face-to-face interview with a mental health clinician over 2 hours. Patients complete multiple psychiatric/psychological assessments during the interview, including the Structured Clinical Interview for DSM-IV (SCID); the Liebowitz Social Anxiety Scale (SAS); the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN); the Social Phobia and Anxiety Inventory (SPAI); the State-Trait Anxiety Inventory (STAI); Response to Stress Questionnaire, Cancer Version (RSQ-CV); the Functional Assessment of Cancer Therapy (FACT-HNC (head neck cancer) or LC); the Voice Handicap Index (VHI); and the Body Image Scale (BIS).
Cancer treatment and medical history information are gathered from patients' medical records.
- Conditions
- Anxiety Disorder, Head and Neck Cancer, Lung Cancer
- Being tested
- Medical chart review, Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory, management of therapy complications, Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID, Functional Assessment of Cancer Therapy-General (FACT-G)
- Keywords
- anxiety disorder, long-term effects secondary to cancer therapy in adults, head and neck cancer, non-small cell lung cancer, small cell lung cancer
- Medical subject headings
- Anxiety Disorders, Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical chart reviewOther
medical chart review
Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety InventoryOther
Also called survey administration
survey administration
management of therapy complicationsProcedure or surgery
management of therapy complications
Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCIDProcedure or surgery
Also called psychosocial assessment
psychosocial assessment
Functional Assessment of Cancer Therapy-General (FACT-G)Other
survey administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of social anxiety and avoidance in HNC patients post-treatment
Measured by the Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory, containing 24 items with each item separately rated for fear as 0 (none), 1 (mild), 2 (moderate) to 3 (severe)and for avoidance behavior as 0 (never), 1 (occasionally), 2 (often), to 3 (usually). Scores are summed with lower values indicating lower levels of social anxiety and avoidance.
Measured: at study entry, day 1
Secondary outcomes (3)
Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance
Assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCID lifetime diagnostic status (pre-cancer diagnosis) and related to the outcome for social anxiety measures. The SCID does not involve a specific scoring of responses. Trained interviewers ask questions that may involve yes/no answers or more detailed explanations. They make their diagnoses based on their experience and training. For this outcome, interviews results will be compared to and contrasted with scores on the Liebowitz Social Anxiety Scale and Social Phobia and Anxiety Inventory.
Measured: at study entry
Quality of Life
Each patient is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded and items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).
Measured: at study entry, day 1
Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer
Measured by the Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory, containing 24 items with each item separately rated for fear as 0 (none), 1 (mild), 2 (moderate) to 3 (severe)and for avoidance behavior as 0 (never), 1 (occasionally), 2 (often), to 3 (usually). Scores are summed with lower values indicating lower levels of social anxiety and avoidance. Scores in study participants will be compared to scores in studies of social anxiety and avoidance in lung cancer patients
Measured: at study entry, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startNov 2003
- Primary completionMar 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kirsten Haman, PhD, Vanderbilt-Ingram Cancer Center
- Investigators
- Kirsten Haman, PhD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483639
- Sponsor's protocol ID
- VICC HN 0397
- Other IDs
- VU-VICC-HN-0397, VU-VICC-IRB-030785
- Status last verified
- Mar 2013
- First submitted
- 6 Jun 2007
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Anxiety and Avoidance in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00483639
- Acronym / sponsor ID
- VICC HN 0397
- Conditions
- Anxiety Disorder, Head and Neck Cancer, Lung Cancer
- Keywords
- anxiety disorder, long-term effects secondary to cancer therapy in adults, head and neck cancer, non-small cell lung cancer, small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Jun 2007 (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.
RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients.
PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.
Detailed description
OBJECTIVES:
- Determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer.
- Determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients.
- Determine the effect of social anxiety and/or avoidance on the quality of life of these patients.
- Investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer.
OUTLINE: This is a cross-sectional study. Patients are stratified according to prior treatment type (significantly impairing [surgery] vs less impairing [chemotherapy/radiotherapy]).
Patients undergo a face-to-face interview with a mental health clinician over 2 hours. Patients complete multiple psychiatric/psychological assessments during the interview, including the Structured Clinical Interview for DSM-IV (SCID); the Liebowitz Social Anxiety Scale (SAS); the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN); the Social Phobia and Anxiety Inventory (SPAI); the State-Trait Anxiety Inventory (STAI); Response to Stress Questionnaire, Cancer Version (RSQ-CV); the Functional Assessment of Cancer Therapy (FACT-HNC (head neck cancer) or LC); the Voice Handicap Index (VHI); and the Body Image Scale (BIS).
Cancer treatment and medical history information are gathered from patients' medical records.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have been treated for head and neck cancer.
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 |
|---|---|---|
| Medical chart reviewmedical chart review | Other | – |
| Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety InventoryAlso: survey administrationsurvey administration | Other | – |
| management of therapy complicationsmanagement of therapy complications | Procedure or surgery | – |
| Structured Clinical Interview for the Diagnostic and Statistical Manual-IV SCIDAlso: psychosocial assessmentpsychosocial assessment | Procedure or surgery | – |
| Functional Assessment of Cancer Therapy-General (FACT-G)survey administration | Other | – |
Primary outcome
Level of social anxiety and avoidance in HNC patients post-treatment
Time frame: at study entry, day 1
Measured by the Liebowitz Social Anxiety Scale and the Social Phobia and Anxiety Inventory, containing 24 items with each item separately rated for fear as 0 (none), 1 (mild), 2 (moderate) to 3 (severe)and for avoidance behavior as 0 (never), 1 (occasionally), 2 (often), to 3 (usually). Scores are summed with lower values indicating lower levels of social anxiety and avoidance.
3 secondary outcomes
Relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance
Time frame: at study entry
Quality of Life
Time frame: at study entry, day 1
Comparison of social anxiety and avoidance in patients with head and neck cancer to patients with lung cancer
Time frame: at study entry, day 1
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 15 Mar 2013.
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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.
Kirsten Haman, PhD principal investigator
Vanderbilt-Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder and Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites 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?
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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Level of social anxiety and avoidance in HNC patients post-treatment (time frame: at study entry, day 1). 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 15 Mar 2013.