The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study
Completed
Conditions studied: Cancer, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00824278
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 289
- Starts
- 2009-01-13
- Expected to finish
- 2018-05-31
- Last updated by the study team
- 2019-12-17
Who can join
Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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