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. \<TAB>

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.