We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Depression and Adherence in Head and Neck Cancer

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.
ClinicalTrials.gov Identifier: NCT00498875
Recruitment Status : Active, not recruiting
First Posted : July 10, 2007
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Oropharyngeal Cancer Head and Neck Cancer Behavioral: Questionnaire Behavioral: Depression Intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Depression and Adherence in Head and Neck Cancer
Actual Study Start Date : March 2005
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Recruitment rate, Patient satisfaction, Attendance, Questionnaire Completion Rates (questionnaire responses) [ Time Frame: 5 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.


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

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 Posted: July 10, 2007    Key Record Dates
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