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.

Study Overview

• Status: Recruiting
• Conditions: Oncology Problem
• Intervention / Treatment: Behavioral: Surveys

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Dennis Bloomfield, MD; Phone Number: 718-818-2707; Email: dbloomfield@rumcsi.org
• Study Contact Backup: Name: Jakey Patwari, MD; Phone Number: 718-818-2707; Email: Jpatwari@rumcsi.org

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10310
      • Recruiting
      • Richmond University Medical Center
      • Contact: Jakey M Patwari, MD; Phone Number: 718-818-2707; Email: Jpatwari@rumcsi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults receiving chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subsequent; Patients who have been receiving chemotherapy more than once. A intervention survey will be administered.	Behavioral: Surveys; GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.
First Time; Patients who have been receiving chemotherapy first time. A intervention survey will be administered.	Behavioral: Surveys; GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Information	To gather demographic information with a Demographic Survey	Two years

Collaborators and Investigators

• Sponsor: Richmond University Medical Center
• Investigators: Study Director: Jakey Patwari, MD, Richmond University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Anticipated): December 20, 2024
• Study Completion (Anticipated): December 20, 2025

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: RUMCPSY-ONC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No