Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer

The Impact of Secondary Lymphedema After Head and Neck Cancer Treatment on Symptoms, Functional Status, and Quality of Life

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01098669

Enrollment

103

Registered

2010-04-05

Start date

2009-12-31

Completion date

2012-02-29

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Survivor, Head and Neck Cancer, Lymphedema

Keywords

cancer survivor, lymphedema, head and neck cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Association between the severity of lymphedema with symptoms, functional status, and quality of life	Cross-sectional
Factors contributing to the development of secondary lymphedema	Cross-sectional Study

Countries

United States

Outcome results