NCT07083674

Brief Summary

This study focuses on improving interprofessional communication during cancer treatment, through an individual and hospital system intervention, to improve provider outcomes, patient care, and, ultimately, survival for children with cancer in low-resource settings.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Sep 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 23, 2027

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

July 8, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

Pediatric CancerCommunication

Outcome Measures

Primary Outcomes (1)

  • Communication quality - CritCom Measure

    Reliable, published measure of communication quality; measured across 6 domains on a Likert scale; self reported by clinical team members; Will assess change in clinician perspective of communication quality within 6 months

    We will evaluate outcomes at three time points; baseline, one month after intervention, and six months after intervention.

Other Outcomes (2)

  • Provider burnout and retention

    We will evaluate outcomes at three time points; baseline, one month after intervention, and six months after intervention.

  • Patient mortality and safety/adverse events

    We will evaluate outcomes at three time points; baseline, one month after intervention, and six months after intervention.

Study Arms (2)

Intervention Group

EXPERIMENTAL

This study includes an intervention development phase (Aim 2) during which the intervention content and delivery mechanisms will be finalized. We will implement the multilevel intervention developed in Aim 2. We anticipate this will consist of one instance of intervention at each hospital and we will develop a full intervention manual following Aim 2. Details regarding the intervention will be updated prior to participant enrollment in the trial.

Behavioral: Multi-level communication intervention

Waitlist Control Group

NO INTERVENTION

The wait list control is a group that does not receive an intervention during the study period, serving as an untreated comparison during the study, although they later receive the intervention. This intervention will be delivered after the completion of the last data collection instance.

Interventions

The intervention will target multiple levels (provider, unit, hospital) and will respond to identified modifiable communication challenges. Aim 2 intervention mapping will finalize the specific intervention; we anticipate it will involve training and education of staff members and new unit protocols for communication.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitals identified as being in lowest quartile of communication quality, as defined by prior cross-sectional CritCom analysis and measured as the overall CritCom score.
  • All Global Alliance hospitals providing childhood cancer care will be eligible to participate.
  • Individual participants will be included if they care for hospitalized children with cancer at risk of deterioration.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • DEVELOPMENT OF A QUANTITATIVE MEASURE (CRITCOM) TO ASSESS THE QUALITY OF INTERDISCIPLINARY COMMUNICATION AROUND PATIENT DETERIORATION IN VARIABLY RESOURCED HOSPITALS

    BACKGROUND
  • Agulnik A, Graetz DE, Carothers BJ, Rivera J, Blakeney EA, Hayes S, Chaitan VL, Cabassa L, Goss CW, Luke DA, Malone S. Strategies to improve healthcare team communication structure and quality in resource-variable childhood cancer hospitals (TeamTalk): a study protocol. Implement Sci Commun. 2025 Nov 17;6(1):124. doi: 10.1186/s43058-025-00811-z.

MeSH Terms

Conditions

NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Sara Malone, LCSW, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel-arm, pilot cluster-randomized wait list-controlled trial to evaluate the intervention compared to control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 24, 2025

Study Start (Estimated)

September 23, 2027

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations