The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00824278

Purpose

PRECIS:

OBJECTIVE:

The purpose of this protocol is to evaluate a measure that would assist clinicians in assessing the presence of psychological distress in children and adolescents with serious medical illnesses.

Aim 1: To assess the inter-rater reliability of the Distress Thermometer by comparing ratings of the patient's distress given by the patient, the primary caregiver and the patient's primary medical provider.

Aim 2: To assess the concurrent validity (i.e. the extent to which a test correlates with other previously validated measures of similar constructs) of the Distress Thermometer, a brief screening tool for psychological distress, as compared to validated measures of psychological symptoms (i.e.

depression, anxiety, pain and fatigue) in patients with pediatric cancer, Neurofibromatosis Type 1 (NF1) and HIV-1 infection.

Aim 3: To assess the acceptability of completing the Distress Thermometer to patients, primary caregivers, and medical providers.

Aim 4: To assess the feasibility of administering the Distress Thermometer to patients with cancer, NF1, and HIV-1 infection.

Secondary Aim 1: To assess the relationship between the caregiver's self-report of psychological symptoms and his or her rating of the patient's level of distress on the Distress Thermometer.

Secondary Aim 2: To assess whether patient ratings on the Distress Thermometer differ between the three diseases, controlling for disease severity.

Secondary Aim 3: To assess the burden and benefits of participating in psychosocial research.

STUDY POPULATION:

All outpatients, ages 7-21, enrolled in a research study in the Pediatric Clinic, with a diagnosis of pediatric cancer, NF-1 or HIV infection will be invited to participate in this study.

DESIGN:

Each patient will complete a brief self-report distress scale (the Distress Thermometer) and standardized measures of depression, anxiety, pain, and fatigue. Additionally, adult patients (18-21 years) will be asked to assess the benefits and burdens of participating in psychosocial research.

Primary caregivers will rate their child's level of distress (using the Distress Thermometer), pain and fatigue and complete a self-report measure assessing their own psychological symptoms in addition to questions assessing the benefits and burdens of participating in psychosocial research.

The primary medical provider (physicians or nurse practitioners) will give their estimation of the patien...

Condition
Cancer HIV Infections

Genetics Home Reference related topics: neurofibromatosis type 1 neurofibromatosis type 2

MedlinePlus related topics: AIDS Cancer Caregivers Neurofibromatosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	90
Study Start Date:	January 2009

Show Detailed Description

Eligibility

Ages Eligible for Study:	7 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:
Age 7 to 21 years.
Must be enrolled in an active protocol at the NIH 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 are not validated in Spanish.)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824278

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Allison TG, Williams DE, Miller TD, Patten CA, Bailey KR, Squires RW, Gau GT. Medical and economic costs of psychologic distress in patients with coronary artery disease. Mayo Clin Proc. 1995 Aug;70(8):734-42.

Barton B, North K. Social skills of children with neurofibromatosis type 1. Dev Med Child Neurol. 2004 Aug;46(8):553-63.

Battles HB, Wiener LS. From adolescence through young adulthood: psychosocial adjustment associated with long-term survival of HIV. J Adolesc Health. 2002 Mar;30(3):161-8.

Study ID Numbers:	090022, 09-M-0022
Study First Received:	January 15, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00824278 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Pediatrics
Distresss Screening
Cancer
Neurofibromatosis
HIV

Pediatric Cancer
HIV
Neurofibromatosis
Distress Screening

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Neurofibromatosis Type 1
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Neurofibromatoses
Retroviridae Infections
Immunologic Deficiency Syndromes
Neurofibromatosis 1

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009