NCT07071116

Brief Summary

The goal of this study to test the feasibility, acceptability, and potential impact of a serious illness communication skills training (CST) tailored to rehabilitation professionals to improve their comfort and confidence in navigating difficult conversations with patients and families. Primary Objectives: Aim 1: To assess feasibility and acceptability of a multidisciplinary co-designed interactive CST program for rehabilitation professionals who care for children with serious illness and their families. Aim 2: To characterize the potential impact of this CST intervention on pediatric rehabilitation professionals. Secondary Objective: Aim 3: To examine the perspectives of bereaved parent educators on participation in the implementation of communication training for rehabilitation professionals.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2025Oct 2026

First Submitted

Initial submission to the registry

July 9, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

July 9, 2025

Last Update Submit

March 16, 2026

Conditions

Keywords

Communication Skills Training (CST)Rehabilitation Professionals

Outcome Measures

Primary Outcomes (4)

  • Proportion of participants who achieve a mean score ≥3 on the Feasibility of Intervention Measure (FIM) scale

    Investigators will compute the mean Feasibility of Intervention Measure (FIM) score for each participant using the Feasibility of Intervention Measure (FIM) and report the proportion of participants who achieve a mean score ≥3. The Feasibility of Intervention Measure (FIM) is used to assess how feasible it is to implement a specific intervention. The FIM measure includes four itemized responses that are scored from one to five (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree) such that one represents the lowest possible mean score and five the highest possible mean score. It is scored by averaging the responses to each of the four questions. Higher scores indicate greater perceived feasibility of the intervention.

    Approximately 3 months post intervention

  • Proportion of participants who achieve a mean score ≥3 on Acceptability of Intervention Measure (AIM) scale

    Investigators will compute the mean Acceptability of Intervention Measure (AIM) score for each participant and report the proportion of participants who achieve a mean score ≥3. The Acceptability of Intervention Measure (AIM) is a four-item scale used to assess the acceptability of an intervention. It is scored by calculating the mean of the responses to its four items, each measured on a 5-point Likert scale(1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). This results in a final score ranging from 1 to 5, with higher scores indicating greater acceptability.

    Approximately 3 months post intervention

  • Proportion of participants who achieve a mean score ≥3 on the Intervention Appropriateness Measure (IAM) scale

    Investigators will compute the mean Intervention Appropriateness Measure (IAM) score for each participant and report the proportion of participants who achieve a mean score ≥3. The Intervention Appropriateness Measure (IAM) is a four-item scale used to assess the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs. Each item is rated on a 5-point Likert scale (1=Completely disagree, 2=Disagree, 3=Neither agree nor disagree, 4=Agree, 5=Completely agree). The score is calculated by averaging the responses to all items. A higher score on the IAM indicates a stronger perception that the intervention is appropriate for the given situation and context.

    Approximately 3 months post intervention

  • Potential impact of this CST intervention on pediatric rehabilitation professionals

    Investigators will calculate the proportions of participants who select "Agree" or "Completely agree" in both the pre- and post-intervention surveys and conduct statistical tests, such as Fisher's exact test or the Chi-square test, to determine whether the change in these proportions over time is statistically significant.

    Prior to the start of the intervention (day 1) and at the end of study, approximately 3 months

Secondary Outcomes (1)

  • Perspectives of bereaved parent educators on participation in the implementation of communication training for rehabilitation professionals.

    Within 3 months post intervention

Study Arms (2)

Licensed rehabilitation professionals

OTHER

Licensed rehabilitation professionals (e.g., physical therapists, occupational therapists, speech-language pathologists) employed at St. Jude Children's Research Hospital actively involved in the care of pediatric oncology patients who will participate in the CST intervention

Other: Communication skills training

St. Jude Bereaved Parent Educators

OTHER

St. Jude Bereaved Parent Educators who have participated as an educator in at least one other institutional educational event and will facilitate the CST intervention

Other: Communication skills training-Facilitator

Interventions

See Detailed Description

Also known as: CST
Licensed rehabilitation professionals

See Detailed Description

Also known as: CST-Facilitator
St. Jude Bereaved Parent Educators

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Licensed rehabilitation professionals (e.g., physical therapists, occupational therapists, speech-language pathologists) employed at St. Jude Children's Research Hospital actively involved in the care of pediatric oncology patients.
  • Willingness to participate in the communication skills training (CST) intervention and associated study activities.
  • St. Jude Bereaved Parent Educators who have participated as an educator in at least one other institutional educational event
  • Willingness to facilitate the communication skills training (CST) intervention and complete associated study activities.

You may not qualify if:

  • Non-rehabilitation professionals
  • Individuals unable to attend the CST intervention session.
  • Individuals unable to attend the CST intervention session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Brittany Cowfer, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Cowfer, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 17, 2025

Study Start

July 9, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available at the time of article publication.
Access Criteria
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations