Depression Screening in Patients Undergoing Radiation Therapy For Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00951184
First received: August 1, 2009
Last updated: March 23, 2011
Last verified: March 2011
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Official Title: | Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Feasibility of a screening procedure for major depression [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rates of major depression as identified in diagnostic telephone interviews [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Sensitivity to changes in depression severity of the PHQ-9, the HSCL-25, and the Structured Clinical Interview for DSM-IV (SCID) [ Designated as safety issue: No ]
- Sociodemographic and clinical correlates with depressive symptoms and major depression [ Designated as safety issue: No ]
- Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview [ Designated as safety issue: No ]
- Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up [ Designated as safety issue: No ]
- Differences in study endpoints based on institution characteristics with regard to existing psychosocial services that are provided on-site and integrated in cancer care [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951184
Locations
| 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 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| 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 | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Principal Investigator: | Lynne Wagner, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00951184 History of Changes |
| Other Study ID Numbers: | CDR0000643316, RTOG-0841 |
| Study First Received: | August 1, 2009 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
depression unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 13, 2013