The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study
Condition: Cancer; HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      Medical illnesses and treatments can cause distress in patients, and medical professionals
      are very interested in identifying distress quickly to ensure that a patient can receive
      appropriate support and treatment. Adult patients often use a screening tool known as the
      Distress Thermometer to indicate the causes and levels of distress they feel. However, little
      work has been done on how to assess distress in pediatric patients. This study will
      investigate the effectiveness of the Distress Thermometer as a tool to accurately measure
      distress in pediatric patients, and determine whether primary caregivers and physicians can
      also use the Distress Thermometer to accurately gauge a patient s levels and sources of
      distress. The study will also investigate the effectiveness of the Distress Thermometer
      compared with other means of measuring fatigue, mood, and pain levels.

      This study will include approximately 90 patients between 7 and 21 years of age who are
      currently enrolled in a National Institutes of Health pediatric research study. It will also
      include responses from the primary caregivers and primary medical providers of the patients
      involved in the study.

      All patients will complete the Distress Thermometer s self-reported distress scale and other
      standardized measures of anxiety, depression, fatigue, and pain. In addition, patients
      between 18 and 21 years of age will be asked to assess the benefits and negative effects of
      participating in psychosocial research.

      On the same day, the patient s primary caregiver and primary medical provider will complete a
      Distress Thermometer survey to estimate the patient s distress level. If either the patient
      or the primary caregiver indicate high levels of distress or mood symptoms, the researchers
      will offer them an opportunity to speak with a mental health professional. The primary
      medical provider will also receive a copy of the responses reported on the patient s Distress
      Thermometer.
    

Detailed description: 
      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.
    

Time perspective: Prospective
Keywords: Pediatrics; Distresss Screening; Cancer; Neurofibromatosis; HIV; Pediatric Cancer; Distress Screening