Oncology Problem Clinical Trial
Official title:
Evaluation of Depression and Anxiety in Chemotherapy Patients
This study will examine the existence and severity of depression and anxiety in patients undergoing chemotherapy at RUMC. Patients currently undergoing initial chemotherapy cycle will be compared to patients undergoing a subsequent chemotherapy cycle. Data will then be collected using standardized depression and anxiety scales to assess if these comorbidities exist and to what severity level. Data already collected for depression and anxiety in patients with chronic, but not cancer, illness will be used as a control. The participants will be screened for signs of psychological distress using three self administered questionnaires: the Generalized Anxiety Disorder 7 item Scale (GAD7) and Patient Health Questionnaire (PHQ9). Demographic information about the participants, including medical and psychiatric history, will also be gathered from their medical records.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 20, 2025 |
Est. primary completion date | December 20, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria:1)Patients (greater than equal to) 18 years of age 2)Patients with a confirmed diagnosis of a solid tumor or hematologic cancer 3)Patients who are able to understand the informed consent and read the selfadministered metrics. 4)Patients undergoing chemotherapy. - Exclusion Criteria: - Patients unable to give informed consent. - Patients with a previous diagnosis of anxiety or depression prior to chemotherapy |
Country | Name | City | State |
---|---|---|---|
United States | Richmond University Medical Center | Staten Island | New York |
United States | Richmond University Medical Center | Staten Island | New York |
United States | Richmond University Medical Center | Staten Island | New York |
Lead Sponsor | Collaborator |
---|---|
Richmond University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic Information | To gather demographic information with a Demographic Survey | Two years | |
Primary | Generalized Anxiety Disorder Screener (GAD-7) | Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD). GAD-7 consists total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for generalized anxiety disorder. | Two years | |
Secondary | Patient Heath Questionnaire-9 (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score =10 had a sensitivity of 88% and a specificity of 88% for major depression. | Two years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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