Clinical trial NCT03552731: Evaluation of Depression and Anxiety in Chemotherapy Patients
Official title: Evaluation of Depression and Anxiety in Chemotherapy Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology Problem
Lead sponsor: Richmond University Medical Center
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults receiving chemotherapy

Brief summary: 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.

Detailed description: The purpose of the study is to see how common Anxiety, Depression and distress are in people who are undergoing treatment for cancer. We want to understand how common these issues are in order to better screen for, and treat people suffering from them. Past studies have shown that people with anxiety or depression and cancer have worse outcomes, and a study evaluating how common these issues are has not been done. Patients presenting for chemotherapy will be identified and approached for participation by members of the research team. The purpose and design of the study will be explained. After informed consent is obtained, the surveys will be administered by the study team. Completing surveys will take 20 minuets. Relevant demographic information will be collected from the patients EMR. Recruitment will extend over one year period. Those determined to be suffering from anxiety or depression will be given the option of psychiatric follow up or intervention.

Eligibility criteria: 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.

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Exclusion Criteria:

* Patients unable to give informed consent.
* Patients with a previous diagnosis of anxiety or depression prior to chemotherapy

Primary outcomes:
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Two years
Secondary outcomes:
measure: Patient Heath Questionnaire-9 (PHQ-9)
timeFrame: Two years
Other outcomes:
measure: Demographic Information
timeFrame: Two years
Locations:
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
Study officials:
affiliation: Richmond University Medical Center
name: Jakey Patwari, MD
role: STUDY_DIRECTOR
References: