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

This study has been completed.
Sponsor:
Collaborator:
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

February 7, 2009
February 20, 2012
May 2008
February 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Late-effect lymphedema symptom checklist [ Designated as safety issue: No ]
  • Psychometric properties of the patient symptom checklist (Phase II) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00840814 on ClinicalTrials.gov Archive Site
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Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

  • Head and Neck Cancer
  • Lymphedema
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00840814
CDR0000612406, P30CA068485, VU-VICC-SUPP-0834, VU-VICC-080206
Not Provided
Jie Deng, Vanderbilt University
Vanderbilt University
National Cancer Institute (NCI)
Principal Investigator: Jie Deng, RN, BSN, MSN Vanderbilt-Ingram Cancer Center
Vanderbilt University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP