CancerNCT02423031
Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress
An observational study of Cancer, run by National Institute of Mental Health (NIMH) at 4 sites in United States.
Trial summary
Background: 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… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cancer
- How many people
- 178 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2015to 10 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric cancer patients
Who may be able to join
- Age 8 to 21 years.
- Must be enrolled in a research protocol at the NIH or receiving cancer treatment or follow-up care at Johns Hopkins, Children s Hospital Colorado, or Levine Children s Hospital 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)
- <TAB>
Who cannot join
- -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 measures.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21218
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Carolinas Medical Center Levine Children's Hospital
Charlotte, North Carolina, 28203
About this study
Background:
- 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.
Read more
Objective:
- To create a screening tool that will help health care providers identify psychological and social distress in young people with serious illnesses.
Eligibility:
- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time of the study.
Design:
- 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 Checking In.
- 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.
Read the detailed description
Objective:
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 trajectory.
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. 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 (PIDs).
Secondary Objective 1: To compare patient and caregiver ratings of Checking In in order to determine agreement rates.
-Study Population:
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
LiFraumeni or PIDs will be invited to participate in this study. Additionally, outpatients
ages 8-21, receiving active cancer treatment or follow-up at Johns Hopkins, Children s
Hospital Colorado, or Levine Children s Hospital will be invited to participate.
-Design:
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 application development.
During phase 3, the electronic version of Checking In will be pilot tested and assessed for feasibility. Sixty 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, and peer relationships, as well as an evidence-based questionnaire for self-harm.
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.
-Outcome Measures
Measures include Checking In; Phase 3 Feasibility Questionnaires, Phase 4 PROMIS measures of Anxiety, Depression, Fatigue, Pain Intensity, Pain Interference, Sleep Disturbance, Self Harm (evidence-based questionnaire) and Peer Relationships; and an Feasibility scale for completion of Checking In. Self- harm and suicide risk questions will only be asked to patients 10 and older.
- Conditions
- Cancer
- Keywords
- Physiological Measures, Emotional Context, Pediatric, Distress Screening, Natural History
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | caregivers of pediatric patients with cancer and other serious illnesses | |
| pediatric patients | pediatric patients with cancer and other serious illnesses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive score on depression, anxiety, pain and fatigue measures
Positive score on depression, anxiety, pain and fatigue measures
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start14 Apr 2015
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maryland Pao, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423031
- Sponsor's protocol ID
- 150109
- Other IDs
- 15-M-0109
- Status last verified
- May 2025
- First submitted
- 18 Apr 2015
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress
- ClinicalTrials.gov ID
- NCT02423031
- Acronym / sponsor ID
- 150109
- Conditions
- Cancer
- Keywords
- Physiological Measures, Emotional Context, Pediatric, Distress Screening, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- 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.
Objective:
- To create a screening tool that will help health care providers identify psychological and social distress in young people with serious illnesses.
Eligibility:
- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time of the study.
Design:
- 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 Checking In.
- 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.
Detailed description
Objective:
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 trajectory.
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. 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 (PIDs).
Secondary Objective 1: To compare patient and caregiver ratings of Checking In in order to determine agreement rates.
-Study Population:
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
LiFraumeni or PIDs will be invited to participate in this study. Additionally, outpatients
ages 8-21, receiving active cancer treatment or follow-up at Johns Hopkins, Children s
Hospital Colorado, or Levine Children s Hospital will be invited to participate.
-Design:
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 application development.
During phase 3, the electronic version of Checking In will be pilot tested and assessed for feasibility. Sixty 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, and peer relationships, as well as an evidence-based questionnaire for self-harm.
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.
-Outcome Measures
Measures include Checking In; Phase 3 Feasibility Questionnaires, Phase 4 PROMIS measures of Anxiety, Depression, Fatigue, Pain Intensity, Pain Interference, Sleep Disturbance, Self Harm (evidence-based questionnaire) and Peer Relationships; and an Feasibility scale for completion of Checking In. Self- harm and suicide risk questions will only be asked to patients 10 and older.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | –caregivers of pediatric patients with cancer and other serious illnesses |
| pediatric patients | – | –pediatric patients with cancer and other serious illnesses |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric cancer patients
Key inclusion criteria (5 listed)
- Age 8 to 21 years.
- Must be enrolled in a research protocol at the NIH or receiving cancer treatment or follow-up care at Johns Hopkins, Children s Hospital Colorado, or Levine Children s Hospital 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)
- <TAB>
Key exclusion criteria (1 listed)
- -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 measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive score on depression, anxiety, pain and fatigue measures
Time frame: Ongoing
Positive score on depression, anxiety, pain and fatigue measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryland Pao, M.D. principal investigator
National Institute of Mental Health (NIMH)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by National Institute of Mental Health (NIMH) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive score on depression, anxiety, pain and fatigue measures (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.