Depression Screening in Patients Undergoing Radiation Therapy For Cancer

Depression Clinical Trial

Official title:

Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951184
• Other study ID #: RTOG 0841
• Secondary ID: CDR0000643316
• Status: Completed
• Phase: N/A
• First received: August 1, 2009
• Last updated: March 17, 2015
• Start date: May 2009
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: November 2014
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Behavioral:
• telephone-based intervention

Other:
• screening questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• assessment of therapy complications

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a screening procedure for major depression		Within 1 week of registration	No
Secondary	Rates of major depression as identified in diagnostic telephone interviews		Within 4 weeks of registration	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Sociodemographic and clinical correlates with depressive symptoms and major depression		Within 4 weeks of registration	No
Secondary	Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview		Within 4 weeks of registration	No
Secondary	Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up		Within 4 weeks of registration	No
Secondary	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	No