ClinicalTrials.gg
Not yet recruitingNCT07908485Updated Nov 2, 2026

Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)

An observational study in Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, sponsored by Children's Oncology Group. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Children's Oncology Group · Observational

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

This study is being done to understand how digital strategies (e.g., electronic health record [EHR]-technology, third-party platforms, and institution-developed solutions) can be used to deliver and respond to evidence-based distress screening at Children's Oncology Group (COG) National Cancer Institute Community Oncology Research Program (NCORP)-affiliated practices with the long-term goal of improving the quality of care and equitable patient access to psychosocial supports.

Read the detailed description

PRIMARY OBJECTIVES:

I. To characterize the institutional context for future implementation of digital distress screening strategies (e.g., electronic health record [EHR]-technology, third-party platforms, and institution-developed solutions).

II. To assess the availability, type, and organizational context of psychosocial staff and services accessible to pediatric patients who screen positive for distress across National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practices serving pediatric patients guided by the Consolidated Framework for Implementation Research (CFIR).

OUTLINE: This is an observational study.

Practices complete the Practice Characteristics and Nomination Form at enrollment. Practice representatives then complete the Practice Respondent Survey and may complete a Practice Respondent Interview on study.

02

Conditions studied

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm
03

In context

Lead sponsor

Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Non-patient providers and other professional disciplines working at a COG NCORP-participating practice

Eligibility criteria

Inclusion Criteria:

  • * Practices must be a COG NCORP-participating practice (i.e., NCORP Site)

    • Non-Patient Providers and Other Professional Disciplines must work at a COG NCORP-participating practice
    • Non-Patient Providers and Other Professional Disciplines must be one of the following provider or other professional discipline types:

      • Physician
      • Advanced practice provider (e.g., nurse practitioner, physician assistant)
      • Nurse
      • Psychologist
      • Social worker
      • Certified child life specialist
      • IT professional (e.g. clinical systems analyst, IT program manager)
      • Clinical informaticist (e.g. physician informaticist, pharmacy informaticist, nursing informaticist)
    • Non-Patient Providers and Other Professional Disciplines must speak and read English
    • All Non-Patient Provider and Other Professional Discipline participants must sign a written
    • All institutional and NCI requirements for human studies must be met
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)

Groups and cohorts

  • Observational

    Practices complete the Practice Characteristics and Nomination Form at enrollment. Practice representatives then complete the Practice Respondent Survey and may complete a Practice Respondent Interview on study.

    Other: Non-Interventional Study

Interventions

  • OtherNon-Interventional Study

    Non-interventional study

    Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

06

What researchers measure

Primary outcomes

  1. CFIR inner setting characteristics

    Will assess organizational structural characteristics (physical, IT, and work infrastructure) and available resources (funding, materials, and equipment) that support and deliver distress screening to patients and caregivers as measured by the CFIR Inner Setting measure and semi-structured interview. Descriptive statistics will be used to understand responses across sites. Means and standard deviations, as well as one and two-way tables and figures will be used to summarize and understand survey responses and inter relationships among inner setting, innovation, screening practices, and site characteristics. Survey responses will be described separately for each respondent type to capture the distinct perspectives and experiences of each group. A quasi-deductive approach will be used to analyze the qualitative data, emphasizing first a deductive approach.

    Time frame: Up to study completion, up to 1 year

  2. CFIR innovation characteristics

    Will assess clinician/staff representative perceptions of the relative advantage, complexity, and compatibility of EHR-integrated distress screening as measured by the CFIR Intervention Characteristics measure and semi-structured interview. Descriptive statistics will be used to understand responses across sites. Means and standard deviations, as well as one and two-way tables and figures will be used to summarize and understand survey responses and inter relationships among inner setting, innovation, screening practices, and site characteristics. Survey responses will be described separately for each respondent type to capture the distinct perspectives and experiences of each group. A quasi-deductive approach will be used to analyze the qualitative data, emphasizing first a deductive approach.

    Time frame: Up to study completion, up to 1 year

  3. Informational assessment of current screening practices

    Will assess availability of psychosocial services, methods and measures used, screening timing, frequency, and repeat screening practices; workflows for responding to positive screens; referral pathways and follow-up procedures; documentation and tracking of screening, referrals, and follow-up activities within the EHR; and metrics used by sites to define and evaluate successful screening programs.

    Time frame: Up to study completion, up to 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07908485
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Apr 5, 2027 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Jordan G Marchak
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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