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Development of a Lymphedema Symptom Checklist in Head and Neck Cancer Patients


N/A
20 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Lymphedema

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Trial Information

Development of a Lymphedema Symptom Checklist in Head and Neck Cancer Patients


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Late-effect lymphedema symptom checklist

Outcome Time Frame:

cross-sectional study

Safety Issue:

No

Principal Investigator

Jie Deng, RN, BSN, MSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000612406

NCT ID:

NCT00840814

Start Date:

May 2008

Completion Date:

February 2012

Related Keywords:

  • Head and Neck Cancer
  • Lymphedema
  • 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
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • salivary gland squamous cell carcinoma
  • stage I salivary gland cancer
  • stage II salivary gland cancer
  • stage III salivary gland cancer
  • Head and Neck Neoplasms
  • Lymphedema

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064