Depression, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
depression, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Gathering information about depression in patients with cancer may help doctors learn more about the disease and plan the best treatment. PURPOSE: This clinical trial is studying depression screening in patients undergoing radiation therapy for cancer.
Detailed description
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.
Interventions
BEHAVIORALtelephone-based intervention
OTHERstudy of socioeconomic and demographic variables
PROCEDUREassessment of therapy complications
PROCEDUREpsychosocial assessment and care
Sponsors
National Cancer Institute (NCI)
NRG Oncology
Radiation Therapy Oncology Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of any tumor type * Scheduled to begin radiotherapy within 2 weeks * Stage I-IV cancer (where applicable) allowed * Pre-existing diagnosis of depression allowed PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Able to speak and read English sufficiently to complete screening instruments * Must have existing land-line or cellular telephone service * Not considered suicidal, psychotic, or otherwise unfit for study participation by cancer center staff clinical judgment * No concurrent medical or psychiatric condition that, in the opinion of the investigator, would potentially pose a risk to the patient as a result of participation in this trial * Not mentally incompetent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior or concurrent combination therapy with surgery, chemotherapy, hormone therapy, or immunotherapy allowed * No concurrent psychotropic medication, psychotherapy, or pharmacotherapy for depression at screening * Not receiving hospice care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of a screening procedure for major depression | Within 1 week of registration |
Secondary
| Measure | Time frame |
|---|---|
| False negative rate and false positive rate of the 9-item Patient Health Questionnaire (PHQ-9) and the 25-item Hopkins Symptom Checklist (HSCL-25) | Within 4 weeks of registration |
| 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 | Within 4 weeks of registration |
| Sensitivity to changes in depression severity of the PHQ-9, the HSCL-25, and the Structured Clinical Interview for DSM-IV (SCID) | Within 4 weeks of registration |
| Rates of major depression as identified in diagnostic telephone interviews | Within 4 weeks of registration |
| Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview | Within 4 weeks of registration |
| Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up | Within 4 weeks of registration |
| Differences in study endpoints based on institution characteristics with regard to existing psychosocial services that are provided on-site and integrated in cancer care | Within 1 week of registration |
| Sociodemographic and clinical correlates with depressive symptoms and major depression | Within 4 weeks of registration |
Countries
United States
Outcome results
None listed