Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress

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ClinicalTrials.gov Identifier: NCT02423031

Recruitment Status : Recruiting

First Posted : April 22, 2015

Last Update Posted : January 13, 2021

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Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description

Brief 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 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.

Condition or disease
Cancer

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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

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Study Type :	Observational
Estimated Enrollment :	410 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	-Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress
Actual Study Start Date :	April 14, 2015
Estimated Primary Completion Date :	August 8, 2024
Estimated Study Completion Date :	August 8, 2025

Groups and Cohorts

Group/Cohort
Caregivers caregivers of pediatric patients with cancer and other serious illnesses
pediatric patients pediatric patients with cancer and other serious illnesses

Outcome Measures

Primary Outcome Measures :

Positive score on depression, anxiety, pain and fatigue measures [ Time Frame: Ongoing ]
Positive score on depression, anxiety, pain and fatigue measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	8 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

pediatric cancer patients

Criteria

INCLUSION CRITERIA:
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)

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EXCLUSION CRITERIA:

-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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423031

Contacts

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Contact: Lori Wiener, Ph.D.	(240) 760-6419	lori.wiener@nih.gov
Contact: Maryland Pao, M.D.	(301) 496-4588	paom@mail.nih.gov

Locations

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United States, Colorado
Children s Hospital Colorado	Recruiting
Aurora, Colorado, United States, 80045
Contact: Robert Casey, Ph.D. 720-777-6594 Robert.casey@childrenscolorado.org
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Kathy Ruble, Ph.D. 410-614-5062 rubleka@jhmi.edu
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov
United States, North Carolina
Carolinas Medical Center	Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Amii Steele, Ph.D. 704-381-9966 Amii.Steele@atriumhealth.org

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

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Principal Investigator:	Maryland Pao, M.D.	National Institute of Mental Health (NIMH)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

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Responsible Party:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT02423031
Other Study ID Numbers:	150109 15-M-0109
First Posted:	April 22, 2015 Key Record Dates
Last Update Posted:	January 13, 2021
Last Verified:	January 7, 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):


Physiological Measures Emotional Context Pediatric Distresss Screening

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