MDACC Study Summary 2004-0390

Study Summary
No. 2004-0390:.......Head And Neck......Eileen H. Shinn......Behavioral Science

Study Summary Title



Study Summary Number:	2004-0390

Study Title:	Depression and Adherence in Head and Neck Cancer

Physician

New Patient Referral



Name:	Eileen H. Shinn	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-0919 Contact us about clinical trials

General Information



Disease Group:	Head And Neck	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	All assessment timepoints will be scheduled to coincide with their clinic appointments. However, if they are not able to come back in for a follow-up assessment, we will be able to collect data through the mail.

Treatment Agents:	None	Home Care:	A structured cognitive-behavioral journal will be given to the patient so that she can use the workbook at home. Brief telephone therapy calls will supplement the workbook.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this behavioral research study is to find out how practical and useful a psychological treatment program would be for cancer patients in their homes.

Study Objectives / Outcomes

The specific aims of the proposed research are:

1. 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.
2. 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.
3. Test the relationship between patients' depression levels and adherence to swallowing
rehabilitation and to dental preventive maintenance regimens.

Study Status Information



Study Activation / Registration Date:	03/15/2005

IRB Review and Approval Date:	07/07/2004

Study Type:

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT00498875
Study Information on Clinical Trials Registry (clinicaltrials.gov)