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

April 6, 2017 updated by: Jie Deng, Vanderbilt University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37064
    - Vanderbilt-Ingram Cancer Center - Cool Springs
  - Nashville, Tennessee, United States, 37064
    - Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Late-effect lymphedema symptom checklist Time Frame: cross-sectional study	cross-sectional study
Psychometric properties of the patient symptom checklist (Phase II) Time Frame: cross-sectional study	cross-sectional study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Jie Deng, RN, BSN, MSN, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 7, 2009

First Submitted That Met QC Criteria