Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer
RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||The Impact of Secondary Lymphedema After Head and Neck Cancer Treatment on Symptoms, Functional Status, and Quality of Life|
- Association between the severity of lymphedema with symptoms, functional status, and quality of life [ Time Frame: Cross-sectional ]
- Factors contributing to the development of secondary lymphedema [ Time Frame: Cross-sectional Study ]
|Study Start Date:||December 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
- To examine the association of secondary lymphedema, symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.
- To examine the possible factors contributing to the development of secondary lymphedema in these patients.
OUTLINE: Participants undergo a physical and external (e.g., submental area) and internal (e.g., larynx, pharynx, and oral cavity) lymphedema examination. Demographics, background, and lymphedema treatment information are also collected. Participants' medical records with head and neck cancer information and treatment are reviewed.
Participants complete surveys on Vanderbilt Head and Neck Symptom (VHNSS), Lymphedema Symptom Intensity and Distress Survey Head and Neck (LSIDS-HN), Functional Assessment Cancer Therapy-Head Neck (FACT-HN), Quality of Life Scale, Hospital Anxiety and Depression Scale (HADS), and Body Image Scale.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098669
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Jie Deng, RN, BSN, MSN||Vanderbilt-Ingram Cancer Center|