Depression and Adherence in Head and Neck Cancer

NCT00498875 | Active Not Recruiting

• 2 other identifiers: 2004-0390NCI-2012-02098
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Cancer; Head and Neck Cancer

Keywords

Oropharyngeal Cancer; Head and Neck Cancer; Depression; Questionnaire; Survey; Interview

Outcome Measures

Primary Outcomes (1)

• Recruitment rate, Patient satisfaction, Attendance, Questionnaire Completion Rates (questionnaire responses)

  5 Years

Study Arms (1)

Questionnaire + Depression Intervention

Behavioral: Questionnaire; Behavioral: Depression Intervention

Interventions

Questionnaire BEHAVIORAL

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.

Also known as: Survey

Questionnaire + Depression Intervention

Depression Intervention BEHAVIORAL

Sessions given over 7 weeks and each lasting 30-45 minutes, that use "cognitive-behavioral" techniques.

Questionnaire + Depression Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Stage I-IV
• At least 18 years of age
• Speak and read English at a 7th grade level
• Are oriented to time, person, and place
• Have a Zubrod performance status of 0-3.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Head and Neck Neoplasms; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eileen H. Shinn, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 10, 2007
• Study Start: March 15, 2005
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)