NCT00840814

Brief Summary

RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment. PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms 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
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

3 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

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
3 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

3.8 years

First QC Date

February 7, 2009

Last Update Submit

April 6, 2017

Conditions

Head and Neck CancerLymphedema

Keywords

lymphedemastage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage I verrucous carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage I squamous cell carcinoma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitysalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancer

Outcome Measures

Primary Outcomes (2)

  • Late-effect lymphedema symptom checklist

    cross-sectional study

  • Psychometric properties of the patient symptom checklist (Phase II)

    cross-sectional study

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult head and neck cancer survivors and Head and neck cancer experts

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Patients meeting the following criteria: * Diagnosis of local squamous cell carcinoma of head and neck * Developed lymphedema after cancer treatment * No current evidence of cancer recurrence * No metastatic disease * Identified from oncology practices at the Vanderbilt-Ingram Cancer Center * Volunteer expert meeting the following criteria: * Member of the Pain and Symptom Management Team at Vanderbilt-Ingram Cancer Center OR faculty member/clinician associated with the Principal Investigator's prior clinical research at Vanderbilt Medical Center * Knowledgeable about the symptoms head and neck cancer patients experience PATIENT CHARACTERISTICS: * No history of psychotic illness PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 months since prior cancer treatment * No concurrent chemotherapy or radiotherapy * No concurrent anti-psychotic medication

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

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphedemaSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland 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

February 7, 2009

First Posted

February 10, 2009

Study Start

May 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

US(3)