Evaluation of Depression and Anxiety in Chemotherapy Patients

NCT ID: NCT03552731

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2025-12-20

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.

Conditions

Oncology Problem

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subsequent

Patients who have been receiving chemotherapy more than once. A intervention survey will be administered.

Surveys

Intervention Type: BEHAVIORAL

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.

Surveys

Intervention Type: BEHAVIORAL

GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.

Interventions

Surveys

GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Richmond University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jakey Patwari, MD

Role: STUDY_DIRECTOR

Richmond University Medical Center

Locations

Richmond University Medical Center

Staten Island, New York, United States

Site Status: RECRUITING

Richmond University Medical Center

Staten Island, New York, United States

Site Status: RECRUITING

Richmond University Medical Center

Staten Island, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dennis Bloomfield, MD

Role: CONTACT

dbloomfield@rumcsi.org

718-818-2707

Jakey Patwari, MD

Role: CONTACT

Jpatwari@rumcsi.org

718-818-2707

Facility Contacts

Dennis Bloomfield, MD

Role: primary

718-818-2707

Jakey Patwari, MD

Role: backup

JPatwari@aol.com

718-818-2707

Dennis Bloomfield, MD

Role: primary

718-818-2707

Jakey Patwari, MD

Role: backup

718-818-2707

Jakey M Patwari, MD

Role: primary

Jpatwari@rumcsi.org

718-818-2707

Other Identifiers

RUMCPSY-ONC

Identifier Type: -

Identifier Source: org_study_id