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Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jie Deng, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00840814
First received: February 7, 2009
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Head and Neck Cancer
Lymphedema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of a Lymphedema Symptom Checklist in Head and Neck Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Late-effect lymphedema symptom checklist [ Time Frame: cross-sectional study ] [ Designated as safety issue: No ]
  • Psychometric properties of the patient symptom checklist (Phase II) [ Time Frame: cross-sectional study ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: May 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult head and neck cancer survivors and Head and neck cancer experts

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840814

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jie Deng, RN, BSN, MSN Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jie Deng, RN, BSN, MSN, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00840814     History of Changes
Other Study ID Numbers: CDR0000612406, P30CA068485, VU-VICC-SUPP-0834, VU-VICC-080206
Study First Received: February 7, 2009
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013