Clinical trial NCT01098669: Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer
Official title: The Impact of Secondary Lymphedema After Head and Neck Cancer Treatment on Symptoms, Functional Status, and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Survivor
Head and Neck Cancer
Lymphedema
Keywords: cancer survivor
lymphedema
head and neck cancer
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-04-05
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult head and neck cancer survivors

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.

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.

Eligibility 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

Primary outcomes:
measure: Association between the severity of lymphedema with symptoms, functional status, and quality of life
timeFrame: Cross-sectional
measure: Factors contributing to the development of secondary lymphedema
timeFrame: Cross-sectional Study
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jie Deng, RN, BSN, MSN
role: PRINCIPAL_INVESTIGATOR
References: