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 : September 12, 2018
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|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||289 participants|
|Official Title:||The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study|
|Study Start Date :||January 13, 2009|
|Study Completion Date :||May 31, 2018|
- Positive score on depression, anxiety, pain and fatigue measures.
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|
|Principal Investigator:||Maryland Pao, M.D.||National Institute of Mental Health (NIMH)|