Evaluation of Depression and Anxiety in Chemotherapy Patients

Recruiting

• Conditions: Oncology Problem
• Interventions: Behavioral: Surveys

• Registration Number: NCT03552731
• Lead Sponsor: Richmond University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-20
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subsequent	Surveys	Patients who have been receiving chemotherapy more than once. A intervention survey will be administered.
First Time	Surveys	Patients who have been receiving chemotherapy first time. A intervention survey will be administered.

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder Screener (GAD-7)	Two years	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.

Secondary Outcome Measures

Name	Time	Method
Patient Heath Questionnaire-9 (PHQ-9)	Two years	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.

Trial Locations

Locations (1)

Richmond University Medical Center; 🇺🇸 Staten Island, New York, United States