Depression Screening in Patients Undergoing Radiation Therapy For Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00951184
First received: August 1, 2009
Last updated: December 4, 2013
Last verified: December 2013
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Feasibility of a screening procedure for major depression [ Time Frame: Within 1 week of registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of major depression as identified in diagnostic telephone interviews [ Time Frame: Within 4 weeks of registration ] [ 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) [ Time Frame: Within 4 weeks of registration ] [ 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 [ Time Frame: Within 4 weeks of registration ] [ 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) [ Time Frame: Within 4 weeks of registration ] [ Designated as safety issue: No ]
  • Sociodemographic and clinical correlates with depressive symptoms and major depression [ Time Frame: Within 4 weeks of registration ] [ Designated as safety issue: No ]
  • Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview [ Time Frame: Within 4 weeks of registration ] [ Designated as safety issue: No ]
  • Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up [ Time Frame: Within 4 weeks of registration ] [ 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 [ Time Frame: Within 1 week of registration ] [ Designated as safety issue: No ]

Enrollment: 463
Study Start Date: May 2009
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00951184     History of Changes
Other Study ID Numbers: RTOG 0841, CDR0000643316
Study First Received: August 1, 2009
Last Updated: December 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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 April 17, 2014