Hematopoietic and Lymphatic System NeoplasmNCT07908485
Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Children's Oncology Group.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2027to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-patient providers and other professional disciplines working at a COG NCORP-participating practice
Who may be able to join
- * 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
Show all 14Show fewer
- 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 informed consent
- All institutional and NCI requirements for human studies must be met
Who cannot join
None listed.
About this study
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:
- 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.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to study completion, up to 1 year
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.
Measured: Up to study completion, up to 1 year
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.
Measured: Up to study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start5 Apr 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jordan G Marchak, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908485
- Sponsor's protocol ID
- ACCL24N1CD
- Other IDs
- NCI-2026-07504, ACCL24N1CD, COG-ACCL24N1CD, ACCL24N1CD, UG1CA189955
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)
- ClinicalTrials.gov ID
- NCT07908485
- Acronym / sponsor ID
- ACCL24N1CD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Study start
- 5 Apr 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- 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.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPractices 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-patient providers and other professional disciplines working at a COG NCORP-participating practice
Key inclusion criteria (14 listed)
- * Practices must be a COG NCORP-participating practice (i.e., NCORP Site)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
CFIR inner setting characteristics
Time frame: Up to study completion, up to 1 year
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.
CFIR innovation characteristics
Time frame: Up to study completion, up to 1 year
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.
Informational assessment of current screening practices
Time frame: Up to study completion, up to 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Related trials for Hematopoietic and Lymphatic System Neoplasm
Active, not recruitingPhase 2
Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HL
Recurrent Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
Not yet recruitingPhase 2
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
Core Binding Factor Alpha Subunits, Hematologic Neoplasms
Active, not recruitingPhase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Peripheral T-cell Lymphomas, Lymphoproliferative Disorders
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
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.
Jordan G Marchak principal investigator
Children's Oncology Group
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Children's Oncology Group.
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 14 inclusion and 0 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
CFIR inner setting characteristics (time frame: Up to study completion, up to 1 year). The study lists 3 primary outcomes in all. 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 2 Nov 2026.