Evaluation of Depression and Anxiety in Chemotherapy Patients

NCT03552731 | Unknown

• 1 other identifier: RUMCPSY-ONC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Heath Questionnaire-9 (PHQ-9)

  Two years

Other Outcomes (1)

• Demographic Information

  Two years

Study Arms (2)

Subsequent

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

Behavioral: Surveys

First Time

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

Behavioral: Surveys

Interventions

Surveys BEHAVIORAL

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

First Time; Subsequent

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults receiving chemotherapy

You may not qualify if:

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

Sponsors & Collaborators

• Richmond University Medical Center: lead

Study Sites (3)

Richmond University Medical Center

Staten Island, New York, 10310, United States

RECRUITING

Richmond University Medical Center

Staten Island, New York, 10310, United States

RECRUITING

Richmond University Medical Center

Staten Island, New York, 10310, United States

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jakey Patwari, MD

  Richmond University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Dennis Bloomfield, MD

CONTACT

718-818-2707; dbloomfield@rumcsi.org

Jakey Patwari, MD

CONTACT

718-818-2707; Jpatwari@rumcsi.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 12, 2018
• Study Start: December 20, 2017
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2025
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)