Psychosocial assessment and care and telephone-based intervention and study of socioeconomic and demographic variables in Depression and Unspecified Adult Solid Tumor, Protocol Specific - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

463

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- New York
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Mission Hospitals - Memorial Campus
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Paoli, Pennsylvania, United States, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
- Wisconsin
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of a screening procedure for major depression Time Frame: Within 1 week of registration	Within 1 week of registration

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of major depression as identified in diagnostic telephone interviews Time Frame: Within 4 weeks of registration	Within 4 weeks of registration
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	Within 4 weeks of registration
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	Within 4 weeks of registration
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	Within 4 weeks of registration
Sociodemographic and clinical correlates with depressive symptoms and major depression Time Frame: Within 4 weeks of registration	Within 4 weeks of registration
Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview Time Frame: Within 4 weeks of registration	Within 4 weeks of registration
Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up Time Frame: Within 4 weeks of registration	Within 4 weeks of registration
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	Within 1 week of registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

NRG Oncology

Investigators

Principal Investigator: Lynne Wagner, MD, Robert H. Lurie Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 1, 2009

First Submitted That Met QC Criteria