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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT00840814
Study type Observational
Source Vanderbilt University
Contact
Status Completed
Phase N/A
Start date May 2008
Completion date February 2012

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