Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT01098669|
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : April 7, 2017
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.
|Condition or disease|
|Cancer Survivor Head and Neck Cancer Lymphedema|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Official Title:||The Impact of Secondary Lymphedema After Head and Neck Cancer Treatment on Symptoms, Functional Status, and Quality of Life|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|