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This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNA-guided choice of therapy | Active Comparator | DNA-guided choice of antidepressant therapy |
|
| Clinical management | Active Comparator | Clinical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA-guided choice of therapy | Diagnostic Test | Buccal swab for DNA genotyping to identify best antidepressant therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale). | Baseline, week 12, month 12 |
| Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale). | Baseline, week 12, month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale | Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale. FACT-G is a quality of life questionnaire with values ranging from 0 (not at all) to 4 (very much). The categories of measure are physical, social/family, emotional and functional well-being. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James K Hicks, PharmD, PhD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
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Patients will be blinded to the genomic results for 12 weeks, with the 12 week time period starting at the time of antidepressant drug prescribing.
| Clinical management | Other | Clinical management to identify best antidepressant therapy |
|