The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Cancer HIV Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study |
Eligibility| Ages Eligible for Study: | 7 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
- 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.)
EXCLUSION CRITERIA:
- 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| Contact: Maryland Pao, M.D. | (301) 496-1338 | paom@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Maryland Pao, M.D. | National Institute of Mental Health (NIMH) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00824278 History of Changes |
| Other Study ID Numbers: | 090022, 09-M-0022 |
| Study First Received: | January 15, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Pediatrics Distresss Screening Cancer Neurofibromatosis |
HIV Pediatric Cancer Distress Screening |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on February 26, 2013
