Emergency Medicine Palliative Care Access (EMPallA)

November 22, 2024 updated by: NYU Langone Health

Emergency Medicine Palliative Care Access (EMPallA)

This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure (New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) < 15 ml/min/m2 or dialysis ; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher, or oxygen-dependent chronic obstructive pulmonary disease (COPD) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1606

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles Ronald Reagan Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
      • San Diego, California, United States, 92103
        • University of California San Diego Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida (UF)
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital/Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital, Troy
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System, Morristown Medical Center
    • New York
      • Brooklyn, New York, United States, 11220
        • NYU Langone Hospital- Brooklyn
      • Mineola, New York, United States, 11501
        • NYU Langone Health Hospital Long Island
      • New York, New York, United States, 10016
        • Bellevue Hospital
      • New York, New York, United States, 10016
        • New York University Langone Tisch Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University (OSU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients:

  • English or Spanish-speaking patients ages 50 years and older
  • Qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation status, or admission for two midnights or less.
  • Qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) < 15 ml/min/m2 or dialysis; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or stage III or IV, or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD)
  • Patients must have health insurance, reside within the geographical area, and have a working telephone.

Informal Caregivers:

  • English or Spanish-speaking primary caregivers (relative or friend who has contact with the patient at least two times per week) ages 18 years and older.

Exclusion Criteria:

  • Patients with dementia identified in the EHR, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility, or chronic care hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nurse-led telephonic case management
  • Telephonic nurses will contact patients within 72 hours of enrollment
  • Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Behavioral: Nurse-led telephonic case management
Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
Active Comparator: Facilitated, outpatient specialty palliative care
  • Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
  • Clinic visits will be scheduled the same day as other specialty appointments if possible
Behavioral: Facilitated,outpatient specialty palliative care
In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: Baseline, Month 6
  • Measured by change from enrollment to 6 months
  • Used to measure a person's quality of life
  • 27 questions total
  • 5-point Likert scale
  • Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
Baseline, Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Emergency Department (ED) Revisits
Time Frame: Up to Month 12
Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction.
Up to Month 12
Number of Inpatient Days
Time Frame: Up to Month 12
Measured from enrollment to 12 months as the number of inpatient days, via self-report and EHR extraction.
Up to Month 12
Proportion of Participants Who Used Hospice
Time Frame: Up to Month 12
Measured from enrollment to 12 months as the proportion of participants who used hospice, via self-report and EHR abstraction.
Up to Month 12
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
Time Frame: Baseline, Month 3
  • Used to measure how often a person feels disconnected from others
  • Three questions total
  • 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often)
  • Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.
  • measured by change from enrollment to 3 months
Baseline, Month 3
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
Time Frame: Baseline, Month 6
  • Used to measure how often a person feels disconnected from others
  • Three questions total
  • 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often)
  • Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.
  • measured by change from enrollment to 6 months
Baseline, Month 6
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
Time Frame: Baseline, Month 12
  • Used to measure how often a person feels disconnected from others
  • Three questions total
  • 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often)
  • Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.
  • measured by change from enrollment to 12 months
Baseline, Month 12
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Time Frame: Baseline, Month 3
  • Used to measure severity of symptoms
  • 10 questions
  • Each item is rated on a 0-10 scale (0= none to 10 worst possible)
  • Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.
  • measured by change from enrollment to 3 months
Baseline, Month 3
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Time Frame: Baseline, Month 6
  • Used to measure severity of symptoms
  • 10 questions
  • Each item is rated on a 0-10 scale (0= none to 10 worst possible)
  • Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.
  • measured by change from enrollment to 6 months
Baseline, Month 6
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Time Frame: Baseline, Month 12
  • Used to measure severity of symptoms
  • 10 questions
  • Each item is rated on a 0-10 scale (0= none to 10 worst possible)
  • Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.
  • measured by change from enrollment to 12 months
Baseline, Month 12
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time Frame: Baseline, Month 3
  • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
  • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
  • measured by change from enrollment to 3 months
Baseline, Month 3
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time Frame: Baseline, Month 6
  • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.

  • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.

    • measured by change from enrollment to 6 months
Baseline, Month 6
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time Frame: Baseline, Month 12
  • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.

  • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.

    • measured by change from enrollment to 12 months
Baseline, Month 12
Caregiver Bereavement, as Measured by the Texas Inventory of Grief
Time Frame: 3 Months Post-Patient Death
  • Measured at 3 months post-patient death
  • Used to measure a caregiver's bereavement
  • 19 items; each rated on a 5-point scale from 0 (never) to 4 (always)
  • Total score is the sum of responses and ranges from 0 to 76; higher scores indicate greater levels of grief
3 Months Post-Patient Death
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
Time Frame: Baseline, Month 3
  • Measured as change from enrollment to Month 3
  • Used to measure a caregiver's strain
  • 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no)
  • Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden
Baseline, Month 3
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
Time Frame: Baseline, Month 6
  • Measured as change from enrollment to Month 6
  • Used to measure a caregiver's strain
  • 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no)
  • Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden
Baseline, Month 6
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
Time Frame: Baseline, Month 12
  • Measured as change from enrollment to Month 12
  • Used to measure a caregiver's strain
  • 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no)
  • Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden
Baseline, Month 12
Change in Quality of Life for Patients, as Measured by the FACT-G
Time Frame: Baseline, Month 3
  • Measured by change from enrollment to 3 months
  • Used to measure a person's quality of life
  • 27 questions total
  • 5-point Likert scale
  • Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
Baseline, Month 3
Change in Quality of Life for Patients, as Measured by the FACT-G
Time Frame: Baseline, Month 12
  • Measured by change from enrollment to 12 months
  • Used to measure a person's quality of life
  • 27 questions total
  • 5-point Likert scale
  • Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
Baseline, Month 12
Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time Frame: Baseline, Month 3
  • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
  • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
  • Measured by change from enrollment to 3 months
Baseline, Month 3
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time Frame: Baseline, Month 6
  • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
  • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
  • Measured by change from enrollment to 6 months
Baseline, Month 6
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time Frame: Baseline, Month 12
  • Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale.
  • Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.
  • Measured by change from enrollment to 6 months
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
University of California, San Diego
University of California, Los Angeles
Northwestern University
Yale University
University of Florida
Ohio State University
University of California, Irvine
Henry Ford Health System
Hackensack Meridian Health
Rush University
Atlantic Health System
Dana-Farber/Brigham and Women's Cancer Center
Beaumont Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Corita R. Grudzen, MD, MSHS, FACEP, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Keith S. Goldfeld, DrPH, MS, MPA, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-01211
  • R-1609-36306 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Keith.Goldfeld@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

Upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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