Depression Screening in Patients Undergoing Radiation Therapy For Cancer
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|ClinicalTrials.gov Identifier: NCT00951184|
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : March 18, 2015
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.
|Condition or disease||Intervention/treatment|
|Depression Unspecified Adult Solid Tumor, Protocol Specific||Behavioral: telephone-based intervention Other: screening questionnaire administration Other: study of socioeconomic and demographic variables Procedure: assessment of therapy complications Procedure: psychosocial assessment and care|
- Assess the feasibility of a screening procedure for major depression in cancer patients undergoing definitive or palliative radiotherapy.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||463 participants|
|Official Title:||Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy|
|Study Start Date :||May 2009|
|Primary Completion Date :||October 2011|
|Study Completion Date :||November 2014|
- Feasibility of a screening procedure for major depression [ Time Frame: Within 1 week of registration ]
- Rates of major depression as identified in diagnostic telephone interviews [ Time Frame: Within 4 weeks of registration ]
- 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Within 4 weeks of registration ]
- Sociodemographic and clinical correlates with depressive symptoms and major depression [ Time Frame: Within 4 weeks of registration ]
- Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview [ Time Frame: Within 4 weeks of registration ]
- Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up [ Time Frame: 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 [ Time Frame: Within 1 week of registration ]
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): NCT00951184
|United States, Illinois|
|Saint Anthony's Hospital at Saint Anthony's Health Center|
|Alton, Illinois, United States, 62002|
|United States, Michigan|
|Butterworth Hospital at Spectrum Health|
|Grand Rapids, Michigan, United States, 49503|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|United States, Missouri|
|David C. Pratt Cancer Center at St. John's Mercy|
|Saint Louis, Missouri, United States, 63141|
|St. John's Regional Health Center|
|Springfield, Missouri, United States, 65804|
|Hulston Cancer Center at Cox Medical Center South|
|Springfield, Missouri, United States, 65807|
|United States, New York|
|CCOP - North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|United States, North Carolina|
|Mission Hospitals - Memorial Campus|
|Asheville, North Carolina, United States, 28801|
|Pardee Memorial Hospital|
|Hendersonville, North Carolina, United States, 28791|
|FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center|
|Pinehurst, North Carolina, United States, 28374|
|United States, Pennsylvania|
|Bryn Mawr Hospital|
|Bryn Mawr, Pennsylvania, United States, 19010|
|Cancer Center of Paoli Memorial Hospital|
|Paoli, Pennsylvania, United States, 19301-1792|
|Lankenau Cancer Center at Lankenau Hospital|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, Wisconsin|
|St. Mary's Hospital Medical Center - Green Bay|
|Green Bay, Wisconsin, United States, 54303|
|St. Vincent Hospital Regional Cancer Center|
|Green Bay, Wisconsin, United States, 54307-3508|
|Principal Investigator:||Lynne Wagner, MD||Robert H. Lurie Cancer Center|