Oncology ProblemNCT03552731
Evaluation of Depression and Anxiety in Chemotherapy Patients
An observational study of Oncology Problem, run by Richmond University Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Oncology Problem
- What is being tested?
- Surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Dec 2017to 20 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
Study population: Adults receiving chemotherapy
Who may be able to join
None listed.
Who cannot join
- Patients unable to give informed consent.
- Patients with a previous diagnosis of anxiety or depression prior to chemotherapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Richmond University Medical Center
Staten Island, New York, 10310
Dennis Bloomfield, MD, 718-818-2707
Jakey Patwari, MD, 718-818-2707, JPatwari@aol.com
- Recruiting
Richmond University Medical Center
Staten Island, New York, 10310
Dennis Bloomfield, MD, 718-818-2707
Jakey Patwari, MD, 718-818-2707
- Recruiting
Richmond University Medical Center
Staten Island, New York, 10310
Jakey M Patwari, MD, 718-818-2707, Jpatwari@rumcsi.org
About this study
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.
Read the 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
- Being tested
- Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysBehavioural
GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Subsequent | Patients who have been receiving chemotherapy more than once. A intervention survey will be administered. Receives: Behavioral: Surveys | |
| First Time | Patients who have been receiving chemotherapy first time. A intervention survey will be administered. Receives: Behavioral: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (1)
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start20 Dec 2017
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richmond University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakey Patwari, MD, Study director, Richmond University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552731
- Sponsor's protocol ID
- RUMCPSY-ONC
- Status last verified
- Mar 2023
- First submitted
- 7 May 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Depression and Anxiety in Chemotherapy Patients
- ClinicalTrials.gov ID
- NCT03552731
- Acronym / sponsor ID
- RUMCPSY-ONC
- Conditions
- Oncology Problem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Richmond University Medical CenterUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subsequent | – | Behavioral: SurveysPatients who have been receiving chemotherapy more than once. A intervention survey will be administered. |
| First Time | – | Behavioral: SurveysPatients who have been receiving chemotherapy first time. A intervention survey will be administered. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults receiving chemotherapy
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients unable to give informed consent.
- Patients with a previous diagnosis of anxiety or depression prior to chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysGAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups. | Behavioural | First Time, Subsequent |
Primary outcome
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.
1 secondary outcome
Patient Heath Questionnaire-9 (PHQ-9)
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakey Patwari, MD study director
Richmond University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology Problem, run by Richmond University Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Bloomfield, MD (718-818-2707, dbloomfield@rumcsi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder Screener (GAD-7) (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.