DepressionNCT00404365
Depression Screening in Patients With Lung Cancer
A study testing counseling intervention, screening questionnaire administration and study of socioeconomic and demographic variables in people with Depression and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Lung Cancer
- What is being tested?
- counseling intervention, screening questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the impact of depression screening in patients with lung cancer when the results of the screening are made available to the patient, the physician, both, or neither on detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
Secondary
- Determine psychological and demographic subsets for the impact of depression screening in these patients when the results of the screening are made available to the patient, the physician, both, or neither on the detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
OUTLINE: This is a multicenter, randomized, double-blind, single-blind, factorial study. Patients are stratified according to participating center (Memorial Sloan-Kettering Cancer Center vs University of Kentucky Markey Cancer Center). Patients are randomized to 1 of 4 screening arms.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Depression, Lung Cancer
- Being tested
- counseling intervention, screening questionnaire administration, study of socioeconomic and demographic variables, psychosocial assessment and care
- 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
- Medical subject headings
- Depression, Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
screening questionnaire administrationOther
study of socioeconomic and demographic variablesOther
psychosocial assessment and careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: counseling intervention; Other: screening questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment
Measured: 2 years
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale
Measured: 2 years
Overall patient experience as measured by Patient Experience Questionnaire
Measured: 2 years
Secondary outcomes (1)
Psychological and demographic subsets of patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lucille P. Markey Cancer Center at University of Kentucky, Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- William Breitbart, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404365
- Sponsor's protocol ID
- Mskcc 06-038
- Other IDs
- R01CA115349, P30CA008748, MSKCC-06038
- Status last verified
- Apr 2013
- First submitted
- 27 Nov 2006
- Last updated
- 1 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00404365
- Acronym / sponsor ID
- Mskcc 06-038
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lucille P. Markey Cancer Center at University of Kentucky, Vanderbilt University
- Study start
- Apr 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the impact of depression screening in patients with lung cancer when the results of the screening are made available to the patient, the physician, both, or neither on detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
Secondary
- Determine psychological and demographic subsets for the impact of depression screening in these patients when the results of the screening are made available to the patient, the physician, both, or neither on the detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
OUTLINE: This is a multicenter, randomized, double-blind, single-blind, factorial study. Patients are stratified according to participating center (Memorial Sloan-Kettering Cancer Center vs University of Kentucky Markey Cancer Center). Patients are randomized to 1 of 4 screening arms.
- 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.
- 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.
- 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.
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (control) | Experimental | Other: counseling intervention, Other: screening questionnaire administration, Other: study of socioeconomic and demographic variables, Procedure: psychosocial assessment and careArm 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. |
| Arm II | Experimental | Other: counseling intervention, Other: screening questionnaire administration, Other: study of socioeconomic and demographic variables, Procedure: psychosocial assessment and careArm 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. |
| Arm III | Experimental | Other: counseling intervention, Other: screening questionnaire administration, Other: study of socioeconomic and demographic variables, Procedure: psychosocial assessment and careArm 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. |
| Arm IV | Experimental | Other: counseling intervention, Other: screening questionnaire administration, Other: study of socioeconomic and demographic variables, Procedure: psychosocial assessment and careArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Arm I (control), Arm II, Arm III, Arm IV |
Primary outcome
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment
Time frame: 2 years
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale
Time frame: 2 years
Overall patient experience as measured by Patient Experience Questionnaire
Time frame: 2 years
1 secondary outcome
Psychological and demographic subsets of patients
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Breitbart, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, screening questionnaire administration and study of socioeconomic and demographic variables in people with Depression and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.