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Evaluation of Depression and Anxiety in Chemotherapy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552731
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Richmond University Medical Center

Study Description
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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.


Condition or disease Intervention/treatment
Oncology Problem 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Depression and Anxiety in Chemotherapy Patients
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : December 20, 2024
Estimated Study Completion Date : December 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Generalized Anxiety Disorder Screener (GAD-7) [ Time Frame: 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 :
  1. Patient Heath Questionnaire-9 (PHQ-9) [ Time Frame: 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.


Other Outcome Measures:
  1. Demographic Information [ Time Frame: Two years ]
    To gather demographic information with a Demographic Survey


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults receiving chemotherapy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552731


Contacts
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Contact: Dennis Bloomfield 718-818-2707 dbloomfield@rumcsi.org
Contact: Anita Trupiano 718-818-2707 atrupiano@rumcsi.org

Locations
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United States, New York
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10310
Contact: Dennis Bloomfield, MD    718-818-2707      
Contact: Jakey Patwari, MD    718-818-2707    JPatwari@aol.com   
Sub-Investigator: Dennis Bloomfield, MD         
Principal Investigator: Joel Idowu, MD         
Sub-Investigator: Jakey Patwari, MD         
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10310
Contact: Dennis Bloomfield, MD    718-818-2707      
Contact: Anita Trupiano, MS    718-818-2707      
Principal Investigator: Dennis Bloomfield, MD         
Principal Investigator: Joel Idowu, MD         
Sub-Investigator: Khushbu Shah, MD         
Sub-Investigator: Safwa Zafar, MD         
Sub-Investigator: Asad Shaikh, MD         
Sub-Investigator: Himanga Kalinga, MD         
Sub-Investigator: Anita Trupiano, MS         
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10310
Contact: Anita M Trupiano, MS    718-818-2707    atrupiano@rumcsi.org   
Sponsors and Collaborators
Richmond University Medical Center
Investigators
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Study Director: Dennis Bloomfield, MD Richmond University Medical Center
More Information
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Responsible Party: Richmond University Medical Center
ClinicalTrials.gov Identifier: NCT03552731    
Other Study ID Numbers: RUMCPSY-ONC
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms