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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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jie Deng, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01098669
First received: April 2, 2010
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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 Phase
Cancer Survivor
Head and Neck Cancer
Lymphedema
Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Association between the severity of lymphedema with symptoms, functional status, and quality of life [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
  • Factors contributing to the development of secondary lymphedema [ Time Frame: Cross-sectional Study ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098669

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

Additional Information:
No publications provided

Responsible Party: Jie Deng, RN, BSN, MSN, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01098669     History of Changes
Other Study ID Numbers: CDR0000669342, P30CA068485, VU-VICC-HN0-9102
Study First Received: April 2, 2010
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014