- Medical problems and treatments can cause stress in some people. Researchers want to learn
more about how to measure distress in young people with medical illnesses. A screening tool
called Checking In will be developed in order to help researchers find ways to identify
concerns and stresses common to this group.
- To create a screening tool that will help health care providers identify psychological and
social distress in young people with serious illnesses.
- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time
of the study.
- Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks
about mood, pain, fatigue, peer relationships, and sleep. During this phase,
participants will be asked about the wording of the questions in Checking In. They will
also talk about what they thought of the questions and if they understood them.
- Phase 2 will not involve participant enrollment. During this phase the researchers will
be working with technologists to develop the software for an electronic version of
- Phase 3 participants will complete an electronic version of Checking In. Researchers
will ask questions about the ease or difficulty of using an electronic screen.
- Phase 4 participants and one of their caregivers will complete an electronic version of
Checking In. They will also complete other questionnaires related to mood, pain fatigue,
peer relationships and sleep. They will be asked their thoughts about using Checking In.
On the same day, their NIH doctor will get summary data about their questionnaire
answers. The doctor will also provide feedback about the summary form.
- Researchers will compare data from Checking In with data from the other questionnaires.
The purpose of this study is to develop and implement Checking In, a brief and interactive
screening measure of distress, designed to identify emotional, physical, social, practical
and spiritual concerns of pediatric patients. An accompanying provider summary sheet that
delineates patient report of distress, will allow providers to triage services to patients
and their families, thereby enhancing patient quality of life throughout the treatment
Objective 1: The primary objective of this protocol is to develop a brief electronic
screening tool, Checking In, which would assist clinicians in assessing the presence of
psychological distress in children and adolescents with cancer and other serious medical
illnesses. The electronic scale, once developed, will meet all of the NIH requirements for
gathering and storing electronic data.
In order to accomplish this aim, the researchers will conduct cognitive interviews with 60
pediatric patients in order to refine the questions and phrasing of items on Checking In. The
results from this phase of the study of will be used to develop the electronic screen, which
will be used to accomplish the remaining aims.
Objective 2: To assess the feasibility of administering Checking In to pediatric patients and
their caregivers. Researchers who administer Checking In will complete a brief questionnaire
rating the feasibility of administration and all barriers encountered.
Objective 3: To assess the feasibility of completing the Checking In screening tool among
pediatric patients with cancer and other serious illnesses and their caregivers. This aim
will be achieved by having the patients and their caregivers answer a brief questionnaire
that assesses how feasible and acceptable they found Checking In to complete.
Objective 4: To establish the utility of the Checking In summary report. Providers will
complete a survey evaluating the usefulness of the summary report to indicate whether: 1) the
report provided useful information, 2) the information was presented in a userfriendly
manner, and 3) the summary report impacted care planning for the child.
Objective 5: To assess the concurrent validity (i.e. the extent to which a test correlates
with other previously validated measures of similar constructs) of Checking In as compared to
validated measures of psychological symptoms (i.e. depression, anxiety, pain and fatigue) in
patients with pediatric cancer, Neurofibromatosis Type 1 (NF1) or Primary Immune Deficiencies
Secondary Objective 1: To compare patient and caregiver ratings of Checking In in order to
determine agreement rates.
This study is taking place at the National Institutes of Health (NIH). All outpatients, ages
8-21, enrolled in a research study either at the Pediatric Clinic or the Primary Immune
Deficiency Clinic at the NIH with a diagnosis of pediatric cancer, NF-1 or PIDs will be
invited to participate in this study.
The initial phase of this study will consist of the researchers conducting cognitive
interviews with 60 patients in order to refine the questions and phrasing of items on
Checking In. Preliminary questions for Checking In were derived and modified from the PI s
previous protocol on the Distress Thermometer. During this first phase, a paper and pencil
version of Checking In will be used.
Results of this initial phase will be used in phase 2 to develop the electronic version of
Checking In. A bid will be conducted through the NIH to hire a technology development group
who will build the Checking In application. This will include the interface development,
graphics, and ability for the application to generate a printout summary report.
De-identified data from both phase 1 and the physician survey will be utilized to guide the
During phase 3, the electronic version of Checking In will be pilot tested and assessed for
feasibility. Thirty quartets, including the patient, parent/caregiver, health care provider
and associated staff member will be interviewed for this phase. Patients and their
parent/caregiver will be given a tablet and asked to complete Checking In. They will then be
asked to complete questionnaires assessing the feasibility of the interface of the Checking
In application as well as it s content. A researcher who is present to ensure that the
application runs smoothly and that the interface is feasible will also complete a feasibility
questionnaire evaluating the interface. Health care providers will be given the associated
summary reports and asked to complete a questionnaire assessing the report content and layout
as well as impact on patient care.
Once the electronic version of Checking In is finalized, researchers will begin phase 4 of
the study. During phase 4, each patient will complete a brief electronic self-report distress
scale, Checking In, and standardized measures of depression, anxiety, pain, fatigue, sleep
disturbance, suicide risk and peer relationships.
Primary caregivers will rate their child s level of distress using Checking In, as well as
complete measures assessing their child s depression, anxiety, pain, fatigue, sleep
disturbance, suicide risk and peer relationships
Both patients and primary caregivers will assess the feasibility of completing Checking In.
Medical providers will rate the usefulness of the Checking In summary report, as well as
provide a performance rating of the patient using Lansky/Karnofsky Performance status scores.
Additionally, data collectors will assess the feasibility of administering Checking In in a
pediatric outpatient clinic.
Measures include Checking In; Phase 3 Feasibility Questionnaires, PROMIS measures of Anxiety,
Depression, Fatigue, Pain Intensity, Pain Interference, Sleep Disturbance and Peer
Relationships; and an Feasibility scale for completion of Checking In.
- INCLUSION CRITERIA:
- Age 8 to 21 years.
- Must be enrolled in a research 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.
- Patients and caregiver must be be able to read in English and write in English (as all
instruments have not been validated in other languages)
-Patients can be excluded from this study if there is a 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