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

NCT ID: NCT01098669

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Cancer Survivor Head and Neck Cancer Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Jie Deng

RN, BSN, MSN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Deng, RN, BSN, MSN

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-HN0-9102

Identifier Type: -

Identifier Source: secondary_id

CDR0000669342

Identifier Type: -

Identifier Source: org_study_id

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