Evaluation of Depression and Anxiety in Chemotherapy Patients

Oncology Problem Clinical Trial

Official title:

Evaluation of Depression and Anxiety in Chemotherapy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552731
• Other study ID #: RUMCPSY-ONC
• Status: Recruiting
• Start date: December 20, 2017
• Est. completion date: December 20, 2025

Study information

• Verified date: March 2023
• Source: Richmond University Medical Center
• Contact: Dennis Bloomfield, MD
• Phone: 718-818-2707
• Email: dbloomfield[@]rumcsi.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2024
• 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.

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Exclusion Criteria:

• Patients unable to give informed consent.

• Patients with a previous diagnosis of anxiety or depression prior to chemotherapy

Related Conditions & MeSH terms

• Depression
• Oncology Problem

Intervention

Behavioral:
• Surveys
GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Richmond University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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