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Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy

21 Years
Open (Enrolling)
Depression, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy



- 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

- 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

- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:


Outcome Measure:

Feasibility of a screening procedure for major depression

Safety Issue:


Principal Investigator

Lynne Wagner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2009

Completion Date:

Related Keywords:

  • Depression
  • Unspecified Adult Solid Tumor, Protocol Specific
  • depression
  • unspecified adult solid tumor, protocol specific
  • Depression
  • Depressive Disorder



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CCOP - Grand RapidsGrand Rapids, Michigan  49503
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St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Pardee Memorial HospitalHendersonville, North Carolina  28791
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792