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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jie Deng, Vanderbilt University

Brief Summary:

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

Detailed Description:

OBJECTIVES:

  • 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
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
Study Start Date : December 2009
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Association between the severity of lymphedema with symptoms, functional status, and quality of life [ Time Frame: Cross-sectional ]
  2. Factors contributing to the development of secondary lymphedema [ Time Frame: Cross-sectional Study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult head and neck cancer survivors
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with head and neck cancer
  • At least 3 months since completion of head and neck cancer treatment
  • Participating in the Pain and Symptom Management Program at the Vanderbilt-Ingram Cancer Center
  • No current evidence of cancer
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • No other active cancer
  • Able to understand informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent chemotherapy or radiotherapy

Information from the National Library of Medicine

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


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jie Deng, RN, BSN, MSN Vanderbilt-Ingram Cancer Center

Responsible Party: Jie Deng, RN, BSN, MSN, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01098669     History of Changes
Other Study ID Numbers: CDR0000669342
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-HN0-9102
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Jie Deng, Vanderbilt University:
cancer survivor
lymphedema
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Lymphatic Diseases