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Depression and Adherence in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00498875
First received: July 6, 2007
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

Primary Objectives:

  • Develop and pilot test an innovative intervention to determine its feasibility and acceptability to patients. Recruitment rate, patient satisfaction, attendance, questionnaire completion rates and the reliability and validity of the questionnaires will be assessed.
  • Conduct preliminary analyses on the efficacy of the intervention in improving patients' depression. Evaluate whether depression levels in patients receiving the intervention decreases, and whether the decrease is greater among those who complete more sessions.
  • Test the relationship between patients' depression levels and adherence to swallowing rehabilitation and to dental preventive maintenance regimens.

Condition Intervention Phase
Oropharyngeal Cancer
Head and Neck Cancer
 Behavioral: Questionnaire
Behavioral: Depression Intervention
 Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Depression and Adherence in Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Recruitment rate, Patient satisfaction, Attendance, Questionnaire Completion Rates (questionnaire responses) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2005
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire + Depression Intervention Behavioral: Questionnaire
Questionnaire regarding mood, coping with cancer, how closely you follow your treatment schedule, your thoughts, your demographic information (such as age and race), and your medical history. If the answers to your questionnaire indicate that you may be depressed, you will be offered the intervention portion of the study.
Other Name: Survey
Behavioral: Depression Intervention
Sessions given over 7 weeks and each lasting 30-45 minutes, that use "cognitive-behavioral" techniques.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study participants with stage I-IV Head and Neck Cancer.

Criteria

Inclusion Criteria:

  1. Stage I-IV
  2. At least 18 years of age
  3. Speak and read English at a 7th grade level
  4. Are oriented to time, person, and place
  5. Have a Zubrod performance status of 0-3.
  6. To be eligible for the pilot depression intervention patients must score 9 or above on the Patient Health Questionnaire (PHQ-9). Additionally, if a patient has an elevated PHQ score and does not meet the cutoff but expresses a desire to be in the intervention in order to relieve his or her depression, then the PI will contact the participant to further assess eligibility for the intervention. Patients who do not make the cut-off will still be included in the study's statistical analyses.

Exclusion Criteria:

1. Do not have other cancer diagnoses, excepting non-melanoma skin cancer.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498875

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eileen H. Shinn, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00498875     History of Changes
Other Study ID Numbers: 2004-0390
Study First Received: July 6, 2007
Last Updated: September 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Oropharyngeal Cancer
Head and Neck Cancer
Depression
 Questionnaire
Survey
Interview

Additional relevant MeSH terms:
Depression
Depressive Disorder
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013