Depression Screening in Patients Undergoing Radiation Therapy For Cancer

NCT00951184 | Completed DMC

• 2 other identifiers: RTOG 0841CDR0000643316
• Study Type: observational
• Target: 463
• Locations: 1 country
• Sites: 16

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.

Conditions

Depression; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

depression; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Feasibility of a screening procedure for major depression

  Within 1 week of registration

Secondary Outcomes (8)

• Rates of major depression as identified in diagnostic telephone interviews

  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)

  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

  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)

  Within 4 weeks of registration

• Sociodemographic and clinical correlates with depressive symptoms and major depression

  Within 4 weeks of registration

Interventions

telephone-based intervention BEHAVIORAL

screening questionnaire administration OTHER

study of socioeconomic and demographic variables OTHER

assessment of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (16)

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lynne Wagner, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2009
• First Posted: August 4, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

US (16)