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

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) HIV-1 infection, Primary Immune Deficiencies
(PIDs), DNA repair diseases, sickle cell disease, and Li-Fraumeni.

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, PIDs, and DNA repair diseases.

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 specific diseases, controlling for disease severity.

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

STUDY POPULATION:

This study is taking place at the National Institutes of Health (NIH) and Medstar Georgetown
University Hospital. All outpatients, ages 7-21, enrolled in a research study either at the
Pediatric Clinic, the Primary Immune Deficiency Clinic, or the Dermatology Clinic at the NIH
with a diagnosis of pediatric cancer, NF-1, HIV, PIDs, and DNA repair, and those at risk for
Li-Fraumeni (P53 positive)syndrome diseases will be invited to participate in this study.
Additionally, all outpatients, ages 7-21, seen at Medstar Georgetown University Hospital for
HIV or sickle cell disease 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, all patients
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, fatigue anxiety and depression, and complete a self-report measure
assessing their own psychological symptoms in addition to questions that assess 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.

- 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.