Trial Information

Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy

OBJECTIVES:

Primary

- Assess the feasibility of a screening procedure for major depression in cancer patients
undergoing definitive or palliative radiotherapy.

Secondary

- Establish the rates of major depression identified through diagnostic telephone
interviews.

- Estimate the false negative rate (1-sensitivity) and false positive rate
(1-specificity) of the 9-item Patient Health Questionnaire (PHQ-9) and the 25-item
Hopkins Symptom Checklist (HSCL-25).

- Compare the false negative rate of 2 items addressing mood disturbance on the PHQ-9
relative to all 9-items on the PHQ-9 and to the HSCL-25.

- Examine the sensitivity to changes in depression severity of the PHQ-9, the HSCL-25,
and the Structured Clinical Interview for DSM-IV (SCID) .

- Correlate both depressive symptoms and major depression in terms of sociodemographic
and clinical variables.

- Establish the nature and adequacy of existing care, patient preferences, treatment
availability, and barriers to depression treatment utilization for patients identified
with major depression using the Assessment of Mental Health Services and Barriers to
Care.

- Assess rates of continued elevations of depressive symptoms, seeking and receipt of
care, and barriers to care at follow-up in these patients.

- Examine the differences in study objectives based on institution characteristics with
regard to existing psychosocial services that are provided on-site and integrated in
cancer care.

OUTLINE: This is a multicenter study.

- Depression screening: Patients complete screening depression questionnaires, including
the Hopkins Symptom Checklist (HSCL-25) and the 9-item Patient Health Questionnaire
(PHQ-9) that includes a 2-item PHQ, and a Health Status Questionnaire at baseline.

- Diagnostic telephone interview: Within 2 weeks, patients who screen positive for
depression and select patients who screen negative for depression undergo a diagnostic
telephone interview that includes modules of the Structured Clinical Interview for
Diagnosis-DSM-IV (SCID) related to major depression, bipolar disorder, adjustment
disorders, and queries concerning past and current mental health treatment and barriers
to treatment. The Assessment of Mental Health Services and Barriers of Care
questionnaire is also administered by the clinical interviewer. Clinical interviewers
provide patients who are found to be depressed with a list of community resources, and
offer assistance in obtaining treatment, if needed. Patients are also encouraged to
discuss these options with their oncology health care team.

- Follow-up interview: At 3 months, patients who receive a research diagnosis of major
depression, dysthymia, bipolar disorder, or cancer-related adjustment disorder in the
initial SCID-DSM-IV undergo another diagnostic telephone interview and are reassessed
for the initiation and continuation of treatment, current depressive symptoms, and
receipt of cancer care. The HSCL-25, PHQ-9, and Assessment of Mental Health Services
and Barriers of Care questionnaires and the SCID-DSM-IV are also administered by the
clinical interviewer. Treatment options and referrals are discussed with patients who
remain depressed and are not in treatment.