Head and Neck CancerNCT00840814
Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer
An observational study of Head and Neck Cancer and Lymphedema, run by Vanderbilt University at 3 sites in United States.
Trial summary
RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment. PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Lymphedema
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Feb 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult head and neck cancer survivors and Head and neck cancer experts
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Patients meeting the following criteria:
- Diagnosis of local squamous cell carcinoma of head and neck
- Developed lymphedema after cancer treatment
- No current evidence of cancer recurrence
- No metastatic disease
- Identified from oncology practices at the Vanderbilt-Ingram Cancer Center
- Volunteer expert meeting the following criteria:
- Member of the Pain and Symptom Management Team at Vanderbilt-Ingram Cancer Center OR faculty member/clinician associated with the Principal Investigator's prior clinical research at Vanderbilt Medical Center
- Knowledgeable about the symptoms head and neck cancer patients experience
PATIENT CHARACTERISTICS:
- No history of psychotic illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior cancer treatment
- No concurrent chemotherapy or radiotherapy
- No concurrent anti-psychotic medication
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Development of a Lymphedema Symptom Checklist in Head and Neck Cancer Patients
RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment.
PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients with head and neck cancer.
Read the detailed description
OBJECTIVES:
- To develop and validate a symptom checklist for late-effect lymphedema in patients with head and neck cancer. (Phase I)
- To examine late-effect lymphedema symptoms in these patients using the preliminary patient-symptom checklist developed in phase I. (Phase II)
- To examine the psychometric properties of the patient symptom checklist. (Phase II)
OUTLINE:
- Phase I: Experts review an initial symptom checklist for late-effect lymphedema symptoms and provide suggestions concerning its revision. The checklist is further revised using the card sorting method. Patients sort cards labeled with symptoms into groups that they feel are appropriate based upon their own symptom experiences. Sorting is performed according to frequency and severity of symptoms. Patients may write down any symptoms which are not listed on the cards.
Patients undergo collection of demographic and lymphedema-related symptom information. Additional medical information is obtained from patients' medical records.
- Phase II: A final symptom checklist for late-effect lymphedema symptoms is constructed based on the preliminary checklist developed in phase I. The psychometric properties of the preliminary checklist are also assessed.
Patients undergo collection of demographic, lymphedema-related symptoms, and medical information as in phase I.
- Conditions
- Head and Neck Cancer, Lymphedema
- Keywords
- lymphedema, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage I verrucous carcinoma of the oral cavity, stage II verrucous carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Late-effect lymphedema symptom checklist
Measured: cross-sectional study
Psychometric properties of the patient symptom checklist (Phase II)
Measured: cross-sectional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2012
- Study completionFeb 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.
- 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
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jie Deng, Vanderbilt University
- Investigators
- Jie Deng, RN, BSN, MSN, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840814
- Sponsor's protocol ID
- CDR0000612406
- Other IDs
- P30CA068485, VU-VICC-SUPP-0834, VU-VICC-080206
- Status last verified
- Apr 2017
- First submitted
- 7 Feb 2009
- Last updated
- 7 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Lymphedema Symptom Checklist in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00840814
- Acronym / sponsor ID
- CDR0000612406
- Conditions
- Head and Neck Cancer, Lymphedema
- Keywords
- lymphedema, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Feb 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.
RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment.
PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients with head and neck cancer.
Detailed description
OBJECTIVES:
- To develop and validate a symptom checklist for late-effect lymphedema in patients with head and neck cancer. (Phase I)
- To examine late-effect lymphedema symptoms in these patients using the preliminary patient-symptom checklist developed in phase I. (Phase II)
- To examine the psychometric properties of the patient symptom checklist. (Phase II)
OUTLINE:
- Phase I: Experts review an initial symptom checklist for late-effect lymphedema symptoms and provide suggestions concerning its revision. The checklist is further revised using the card sorting method. Patients sort cards labeled with symptoms into groups that they feel are appropriate based upon their own symptom experiences. Sorting is performed according to frequency and severity of symptoms. Patients may write down any symptoms which are not listed on the cards.
Patients undergo collection of demographic and lymphedema-related symptom information. Additional medical information is obtained from patients' medical records.
- Phase II: A final symptom checklist for late-effect lymphedema symptoms is constructed based on the preliminary checklist developed in phase I. The psychometric properties of the preliminary checklist are also assessed.
Patients undergo collection of demographic, lymphedema-related symptoms, and medical information as in phase I.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult head and neck cancer survivors and Head and neck cancer experts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Late-effect lymphedema symptom checklist
Time frame: cross-sectional study
Psychometric properties of the patient symptom checklist (Phase II)
Time frame: cross-sectional study
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 7 Apr 2017.
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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.
Jie Deng, RN, BSN, MSN principal investigator
Vanderbilt-Ingram Cancer Center
3 sites 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 Lymphedema, run by Vanderbilt University at 3 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Late-effect lymphedema symptom checklist (time frame: cross-sectional study). The study lists 2 primary outcomes in all. 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 7 Apr 2017.