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

Completed

• Conditions: Head and Neck Cancer; Lymphedema

• Registration Number: NCT00840814
• Lead Sponsor: Vanderbilt University

Brief 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.

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-02-07
• Study First Submitted QC: 2009-02-07
• Study First Posted: 2009-02-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychometric properties of the patient symptom checklist (Phase II)	cross-sectional study
Late-effect lymphedema symptom checklist	cross-sectional study

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States