Depression Screening in Patients With Lung Cancer

NCT00404365 | Completed

• 4 other identifiers: Mskcc 06-038R01CA115349P30CA008748MSKCC-06038
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Screening tests may help doctors find depression in patients with lung cancer, allow doctors to recommend treatment for depression, and improve the patient's quality of life. PURPOSE: This randomized clinical trial is studying how well depression screening works when the results are or are not shared with patients with lung cancer and their doctor.

Conditions

Depression; Lung Cancer

Keywords

depression; extensive stage small cell lung cancer; limited stage small cell lung cancer; recurrent small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (3)

• Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment

  2 years

• Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale

  2 years

• Overall patient experience as measured by Patient Experience Questionnaire

  2 years

Secondary Outcomes (1)

• Psychological and demographic subsets of patients

  2 years

Study Arms (4)

Arm I (control)

EXPERIMENTAL

Arm I (control): Patients complete screening questionnaires about their mood and experience with lung cancer once before and once after a visit with their physician. Neither the patient nor physician receives the screening results before the visit.

Other: counseling intervention; Other: screening questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

Arm II

EXPERIMENTAL

Arm II: Patients complete screening questionnaires as in arm I. Only the patient receives the screening results before their visit with the physician; the physician remains blinded to the results.

Other: counseling intervention; Other: screening questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

Arm III

EXPERIMENTAL

Arm III: Patients complete screening questionnaires as in arm I. Only the physician receives the screening results before their visit with the patient; the patient remains blinded to the results.

Other: counseling intervention; Other: screening questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

Arm IV

EXPERIMENTAL

Arm IV: Patients complete screening questionnaires as in arm I. Both physician and patient receive the screening results before the visit. All patients and physicians are notified of the screening results before the patient leaves the clinic. All patients are offered supportive counseling.

Other: counseling intervention; Other: screening questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

Interventions

counseling intervention OTHER

Arm I (control); Arm II; Arm III; Arm IV

screening questionnaire administration OTHER

Arm I (control); Arm II; Arm III; Arm IV

study of socioeconomic and demographic variables OTHER

Arm I (control); Arm II; Arm III; Arm IV

psychosocial assessment and care PROCEDURE

Arm I (control); Arm II; Arm III; Arm IV

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of lung cancer * Prescreening distress thermometer score \> 3 * Zung Self-Rating Depression Scale (ZSDS) score ≥ 44 * No ZSDS response indicating suicidality PATIENT CHARACTERISTICS: * Able to understand English * No evidence of cognitive dysfunction that would impair giving consent PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Lucille P. Markey Cancer Center at University of Kentucky: collaborator
• Vanderbilt University: collaborator

Study Sites (2)

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depression; Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Counseling; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Therapeutics

Study Officials

• William Breitbart, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (2)