DepressionNCT00951184
Depression Screening in Patients Undergoing Radiation Therapy For Cancer
An observational study of Depression and Unspecified Adult Solid Tumor, Protocol Specific, run by Radiation Therapy Oncology Group at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- telephone-based intervention, screening questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 463 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2009to Nov 2014
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374
St. John's Regional Health Center
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
About this study
Official title: Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy
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.
Read the 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.
- Being tested
- telephone-based intervention, screening questionnaire administration, study of socioeconomic and demographic variables, assessment of therapy complications, psychosocial assessment and care
- Keywords
- depression, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
screening questionnaire administrationOther
study of socioeconomic and demographic variablesOther
assessment of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a screening procedure for major depression
Measured: Within 1 week of registration
Secondary outcomes (8)
Rates of major depression as identified in diagnostic telephone interviews
Measured: 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)
Measured: 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
Measured: 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)
Measured: Within 4 weeks of registration
Sociodemographic and clinical correlates with depressive symptoms and major depression
Measured: Within 4 weeks of registration
Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview
Measured: Within 4 weeks of registration
Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up
Measured: 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
Measured: Within 1 week of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2011
- Study completionNov 2014
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Lynne Wagner, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951184
- Sponsor's protocol ID
- RTOG 0841
- Other IDs
- CDR0000643316
- Status last verified
- Mar 2015
- First submitted
- 1 Aug 2009
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT00951184
- Acronym / sponsor ID
- RTOG 0841
- Keywords
- depression, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- May 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Aug 2009 (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: 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
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 |
|---|---|---|
| telephone-based intervention | Behavioural | – |
| screening questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Feasibility of a screening procedure for major depression
Time frame: Within 1 week of registration
8 secondary outcomes
Rates of major depression as identified in diagnostic telephone interviews
Time frame: 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
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
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
Sociodemographic and clinical correlates with depressive symptoms and major depression
Time frame: 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
Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up
Time frame: 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
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 18 Mar 2015.
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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.
Lynne Wagner, MD principal investigator
Robert H. Lurie Cancer Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Unspecified Adult Solid Tumor, Protocol Specific, run by Radiation Therapy Oncology Group at 16 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Feasibility of a screening procedure for major depression (time frame: Within 1 week of registration). 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 18 Mar 2015.