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Depression and Adherence in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498875
First Posted: July 10, 2007
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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
Oropharyngeal Cancer Head and Neck Cancer Behavioral: Questionnaire Behavioral: Depression Intervention

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:


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 ]

Estimated Enrollment: 350
Actual Study Start Date: March 2005
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498875


Locations
United States, Texas
University of Texas 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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00498875     History of Changes
Other Study ID Numbers: 2004-0390
NCI-2012-02098 ( Registry Identifier: NCI CTRP )
First Submitted: July 6, 2007
First Posted: July 10, 2007
Last Update Posted: September 29, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
Depression
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Behavioral Symptoms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases