Clinical trial NCT00951184: Depression Screening in Patients Undergoing Radiation Therapy For Cancer
Official title: Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: depression
unspecified adult solid tumor, protocol specific
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2009-08-04
Enrollment: 463
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (at least age 21) cancer patients who are undergoing radiation therapy for their first diagnosis of cancer with no mental incompetence which would preclude completion of questionnaires, who is not considered suicidal or psychotic or otherwise unfit for study participation. Patient must provide study-specific consent prior to screening.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of a screening procedure for major depression
timeFrame: Within 1 week of registration
Secondary outcomes:
measure: Rates of major depression as identified in diagnostic telephone interviews
timeFrame: Within 4 weeks of registration
measure: 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)
timeFrame: Within 4 weeks of registration
measure: 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
timeFrame: Within 4 weeks of registration
measure: Sensitivity to changes in depression severity of the PHQ-9, the HSCL-25, and the Structured Clinical Interview for DSM-IV (SCID)
timeFrame: Within 4 weeks of registration
measure: Sociodemographic and clinical correlates with depressive symptoms and major depression
timeFrame: Within 4 weeks of registration
measure: Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview
timeFrame: Within 4 weeks of registration
measure: Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up
timeFrame: Within 4 weeks of registration
measure: Differences in study endpoints based on institution characteristics with regard to existing psychosocial services that are provided on-site and integrated in cancer care
timeFrame: Within 1 week of registration
Other outcomes:
Locations:
city: Alton
country: United States
facility: Saint Anthony's Hospital at Saint Anthony's Health Center
state: Illinois
city: Grand Rapids
country: United States
facility: Butterworth Hospital at Spectrum Health
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Saint Louis
country: United States
facility: David C. Pratt Cancer Center at St. John's Mercy
state: Missouri
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospitals - Memorial Campus
state: North Carolina
city: Hendersonville
country: United States
facility: Pardee Memorial Hospital
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
state: North Carolina
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Paoli
country: United States
facility: Cancer Center of Paoli Memorial Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: Green Bay
country: United States
facility: St. Mary's Hospital Medical Center - Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital Regional Cancer Center
state: Wisconsin
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Lynne Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: