NCT01098669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

April 2, 2010

Last Update Submit

April 6, 2017

Conditions

Cancer SurvivorHead and Neck CancerLymphedema

Keywords

cancer survivorlymphedemahead and neck cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult head and neck cancer survivors

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jie Deng, RN, BSN, MSN

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, BSN, MSN

Study Record Dates

First Submitted

April 2, 2010

First Posted

April 5, 2010

Study Start

December 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(2)