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

Vanderbilt University

Status: Completed

Conditions: Lymphedema; Head and Neck Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00840814

P30CA068485 (U.S. NIH Grant/Contract)

CDR0000612406

VU-VICC-080206

VU-VICC-SUPP-0834

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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