![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00824278 |
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 patient's distress (using the Distress Thermometer).
All patients, primary caregivers and medical providers will assess the acceptability of completing the Distress Thermometer. Additionally, data collectors will assess the feasibility of administering the Distress Thermometer in a pediatric clinic.
MEASURES:
Measures include the Distress Thermometer, a brief screening tool consisting of a single item rating of distress and a list of possible reasons for distress; the Children's Depression Inventory (CDI); the Brief Symptom Inventory 18 (BSI-18); the State Trait Anxiety Inventory (STAI); the Wong-Baker FACES Pain Scale; the Children's Fatigue Scales; an Acceptability and Feasibility scale for completion of the Distress Thermometer; and two questions regarding perception of research participation.
Condition |
---|
Cancer HIV Infections |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory, Pilot Study |
Ages Eligible for Study: | 7 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 090022, 09-M-0022 |
Study First Received: | January 15, 2009 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00824278 |
Health Authority: | United States: Federal Government |
Pediatrics Distresss Screening Cancer Neurofibromatosis HIV |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Neurofibromatoses Retroviridae Infections Neurofibromatosis type 1 Immunologic Deficiency Syndromes Neurofibromatosis 1 |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |