NCT00544336

Brief Summary

RATIONALE: Developing a questionnaire that can be used to assess the quality of life among people who have a family member with cancer may help the study of cancer in the future. PURPOSE: This clinical trial is studying quality of life among families with a member who is a cancer patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

October 13, 2007

Last Update Submit

September 7, 2012

Conditions

Breast CancerColorectal CancerHead and Neck CancerLung CancerProstate CancerSolid Tumor

Keywords

unspecified adult solid tumor, protocol specificrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent prostate cancerstage I prostate cancerstage II prostate cancerstage III prostate cancerstage IV prostate cancerextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent non-small cell lung cancerrecurrent small cell lung cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerrecurrent squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage 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 IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavitystage 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 IV squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage II basal cell carcinoma of the lipstage III basal cell carcinoma of the lipstage IV basal cell carcinoma of the lipmetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primaryrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityhigh-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomarecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancer

Outcome Measures

Primary Outcomes (4)

  • Preliminary validation of a family quality of life questionnaire

    Off study date

  • Generation of an initial item pool (step 1)

    Off study date

  • Reduction of the item pool based on content validity assessment (step 2)

    Off study date

  • Psychometric properties and dimensionality of the measure (step 3)

    Off study date

Study Arms (1)

Supportive

Other: questionnaire administrationOther: survey administrationProcedure: quality-of-life assessment

Interventions

questionnaire administrationOTHER

no intervention

Supportive
survey administrationOTHER

no intervention

Supportive
quality-of-life assessmentPROCEDURE

no intervention

Supportive

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Family members of a patient with cancer

You may qualify if:

  • Patients diagnosed with any local, advanced, or metastatic cancer that has required more than a simple surgical procedure
  • Ten families with an adult patient with breast, prostate, lung, colon, or head and neck cancer are interviewed for step 1 portion of the study
  • An available adult family member willing to participate in the study
  • The term family is defined broadly to include adults over 21 years of age, considered by the cancer patient as a family member, who provides care or support and/or shares the cancer experience with the patient
  • Family members do not need to be biologically related to the patient or related through marriage, and may or may not live in the same house with the patient

You may not qualify if:

  • Able to read, write, and speak English
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contact the study team to confirm eligibility.

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

Breast NeoplasmsColorectal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsProstatic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaColonic NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Barbara Murphy, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

First Submitted

October 13, 2007

First Posted

October 16, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2009

Study Completion

May 1, 2009

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

US(3)