Protocol Number: 09-M-0022

Title:

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

Number:

09-M-0022

Summary:

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Pediatrics

Distresss Screening

Cancer

Neurofibromatosis

HIV

Recruitment Keyword(s):

Pediatric Cancer

HIV

Neurofibromatosis

Distress Screening

Condition(s):

Cancer

HIV Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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