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

Head and Neck Cancer Clinical Trial

Official title:

Development of a Lymphedema Symptom Checklist in Head and Neck Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840814
• Other study ID #: CDR0000612406
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: February 7, 2009
• Last updated: April 6, 2017
• Start date: May 2008
• Est. completion date: February 2012

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late-effect lymphedema symptom checklist		cross-sectional study
Primary	Psychometric properties of the patient symptom checklist (Phase II)		cross-sectional study