NCT00105651

Brief Summary

Data from the Surveillance, Epidemiology and End Results (SEER) cancer registry indicates that head and neck cancers (HN Ca) are nearly twice as common in veterans as non-veterans. HN Ca patients are at an increased risk for smoking, alcohol consumption and depression, all of which contribute to a further decline in their quality of life (QoL). In the HN Ca population, diagnosis and treatment of smoking, alcohol intake and depression are sub-optimal, thereby affecting QoL and survival. Numerous studies have documented that smoking, alcohol and depression are interrelated and research on multi-modal interventions has been suggested.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2005

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 16, 2005

Last Update Submit

April 6, 2015

Conditions

Cancer

Study Arms (1)

Arm 1

OTHER
Behavioral: Combined nursing invention

Interventions

Combined nursing inventionBEHAVIORAL
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Related Publications (10)

  • Lambert MT, Terrell JE, Copeland LA, Ronis DL, Duffy SA. Cigarettes, alcohol, and depression: characterizing head and neck cancer survivors in two systems of care. Nicotine Tob Res. 2005 Apr;7(2):233-41. doi: 10.1080/14622200500055418.

    PMID: 16036280RESULT

  • Taylor JC, Terrell JE, Ronis DL, Fowler KE, Bishop C, Lambert MT, Myers LL, Duffy SA, Bradford CR, Chepeha DB, Hogikyan ND, Prince ME, Teknos TN, Wolf GT; University of Michigan Head and Neck Cancer Team. Disability in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2004 Jun;130(6):764-9. doi: 10.1001/archotol.130.6.764.

    PMID: 15210560RESULT

  • Cheng SS, Terrell JE, Bradford CR, Ronis DL, Fowler KE, Prince ME, Teknos TN, Wolf GT, Duffy SA. Variables associated with feeding tube placement in head and neck cancer. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):655-61. doi: 10.1001/archotol.132.6.655.

    PMID: 16785412RESULT

  • Terrell JE, Ronis DL, Fowler KE, Bradford CR, Chepeha DB, Prince ME, Teknos TN, Wolf GT, Duffy SA. Clinical predictors of quality of life in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2004 Apr;130(4):401-8. doi: 10.1001/archotol.130.4.401.

    PMID: 15096421RESULT

  • Duffy SA, Terrell JE, Valenstein M, Ronis DL, Copeland LA, Connors M. Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients. Gen Hosp Psychiatry. 2002 May-Jun;24(3):140-7. doi: 10.1016/s0163-8343(02)00180-9.

    PMID: 12062138RESULT

  • Duffy SA, Jackson FC, Schim SM, Ronis DL, Fowler KE. Racial/ethnic preferences, sex preferences, and perceived discrimination related to end-of-life care. J Am Geriatr Soc. 2006 Jan;54(1):150-7. doi: 10.1111/j.1532-5415.2005.00526.x.

    PMID: 16420213RESULT

  • Duffy SA, Ronis DL, Valenstein M, Fowler KE, Lambert MT, Bishop C, Terrell JE. Depressive symptoms, smoking, drinking, and quality of life among head and neck cancer patients. Psychosomatics. 2007 Mar-Apr;48(2):142-8. doi: 10.1176/appi.psy.48.2.142.

    PMID: 17329608RESULT

  • Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8. doi: 10.1158/1055-9965.EPI-05-0880.

    PMID: 17119047RESULT

  • Duffy SA, Ronis D, Fowler K, Schim SM, Jackson FC. Differences in veterans' and nonveterans' end-of-life preferences: a pilot study. J Palliat Med. 2006 Oct;9(5):1099-105. doi: 10.1089/jpm.2006.9.1099.

    PMID: 17040147RESULT

  • Karvonen-Gutierrez CA, Ronis DL, Fowler KE, Terrell JE, Gruber SB, Duffy SA. Quality of life scores predict survival among patients with head and neck cancer. J Clin Oncol. 2008 Jun 1;26(16):2754-60. doi: 10.1200/JCO.2007.12.9510.

    PMID: 18509185RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sonia A. Duffy, PhD MS RN

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

  • Larry Myers, MD

    VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2005

First Posted

March 17, 2005

Study Completion

March 1, 2004

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(2)