Recruiting

Observational StudyEvaluation of Depression and Anxiety in Chemotherapy Patients

Sponsor:

Richmond University Medical Center

Code:

NCT03552731

Conditions

Oncology Problem

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Surveys

Study Details

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.

Conditions

Oncology Problem

Study ID

NCT03552731

Start date

Dec 20, 2017

Status verified date

Mar, 2023

Completion date

Dec 20, 2025

Anticipated

Primary completion date

Dec 20, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Subsequent

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

First Time

Patients who have been receiving chemotherapy first time. A intervention survey will be administered.

Interventions

Surveys

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

Primary outcome measure

Generalized Anxiety Disorder Screener (GAD-7) [ Time Frame: Two years ]

Central Contacts and Locations

Central contacts

Dennis Bloomfield, MD

718-818-2707 dbloomfield@rumcsi.org

Jakey Patwari, MD

718-818-2707 Jpatwari@rumcsi.org

Locations

Richmond University Medical Center

Recruiting

Staten Island, New York, United States, 10310

Contacts

Dennis Bloomfield, MD

718-818-2707

Jakey Patwari, MD

718-818-2707 JPatwari@aol.com

Principal Investigator:

Joel Idowu, MD

Richmond University Medical Center

Recruiting

Staten Island, New York, United States, 10310

Contacts

Dennis Bloomfield, MD

718-818-2707

Jakey Patwari, MD

718-818-2707

Principal Investigator:

Joel Idowu, MD

Richmond University Medical Center

Recruiting

Staten Island, New York, United States, 10310

Contacts

Jakey M Patwari, MD

718-818-2707 Jpatwari@rumcsi.org

More Information

Sponsor

Richmond University Medical Center

Last update posted

Apr 4, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Richmond University Medical Center on 2023-04-04.