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The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study

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ClinicalTrials.gov Identifier: NCT00824278
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Medical illnesses and treatments can cause distress in patients, and medical professionals are very interested in identifying distress quickly to ensure that a patient can receive appropriate support and treatment. Adult patients often use a screening tool known as the Distress Thermometer to indicate the causes and levels of distress they feel. However, little work has been done on how to assess distress in pediatric patients. This study will investigate the effectiveness of the Distress Thermometer as a tool to accurately measure distress in pediatric patients, and determine whether primary caregivers and physicians can also use the Distress Thermometer to accurately gauge a patient s levels and sources of distress. The study will also investigate the effectiveness of the Distress Thermometer compared with other means of measuring fatigue, mood, and pain levels.

This study will include approximately 90 patients between 7 and 21 years of age who are currently enrolled in a National Institutes of Health pediatric research study. It will also include responses from the primary caregivers and primary medical providers of the patients involved in the study.

All patients will complete the Distress Thermometer s self-reported distress scale and other standardized measures of anxiety, depression, fatigue, and pain. In addition, patients between 18 and 21 years of age will be asked to assess the benefits and negative effects of participating in psychosocial research.

On the same day, the patient s primary caregiver and primary medical provider will complete a Distress Thermometer survey to estimate the patient s distress level. If either the patient or the primary caregiver indicate high levels of distress or mood symptoms, the researchers will offer them an opportunity to speak with a mental health professional. The primary medical provider will also receive a copy of the responses reported on the patient s Distress Thermometer.

Condition or disease
Cancer HIV Infections

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Study Design

Study Type : Observational
Actual Enrollment : 257 participants
Time Perspective: Prospective
Official Title: The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study
Study Start Date : January 13, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Positive score on depression, anxiety, pain and fatigue measures.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Age 7 to 21 years.
  • Must be enrolled in a research protocol at the NIH or receiving medical treatment at Georgetown's Medical Center and be an outpatient at time of study. The treatment protocol PI will be contacted before a patient is approached to ensure that the patient is appropriate for enrollment into this protocol.
  • Must have a parent/guardian available to complete the study measures.
  • For patients less than 18 years of age, a legal guardian must provide informed consent and the patients must sign an assent document.
  • Patients greater than or equal to 18 years of age must give informed consent and their parents need to sign the parent consent.
  • Patients must speak English (as all instruments have not been validated in languages other than English.)


- Presence of psychotic symptoms or cognitive impairment, which in the judgment of the Principal or Associate Investigator, or consulting psychiatrist would compromise the patient s ability to accurately complete the measures.

Contacts and Locations

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): NCT00824278

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: Maryland Pao, M.D. National Institute of Mental Health (NIMH)
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00824278     History of Changes
Other Study ID Numbers: 090022
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: June 15, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Distresss Screening
Pediatric Cancer
Distress Screening

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases