Dissemination and Implementation of DIGEST™ as an Evidenc... | NCT07283653

Studies
Dissemination and Implementation of DIGEST™ as an Evidence-based Measurement Tool for Dysphagia: A Randomized Implementation Trial

NCT07283653

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

85Estimated

Phase

Not Applicable

Conditions

DIGEST
Evidence Based Measurement
Dysphagia
Randomized Implementation

Interventions

No intervention
DIGEST Training Program
DIGEST Training + Practice Facilitation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Aug 1, 2027Estimated

Completion Date

Jan 31, 2029Estimated

First Submitted Date

Dec 10, 2025

First Submission Date that Met QC Criteria

Dec 10, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To improve swallowing outcomes in cancer through clinical implementation of the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST™) as an evidence-based practice (EBP) tool to grade pharyngeal dysphagia (difficulty swallowing) as a toxicity of cancer.

Detailed Description

Primary Objective Assess the impact of implementation strategies on clinical adoption (reach) of DIGEST for oncology MBS studies.

Secondary Objective Assess the impact of implementation strategies on the fidelity (reliability) of DIGEST adoption for oncology MBS studies

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Arm 1	Experimental	The control arm will receive no active implementation strategy.	Other: No intervention
Training Arm 2	Experimental	Represents a low intensity implementation strategy solely using the DIGEST training program as the intervention.	Other: DIGEST Training Program
Training + Practice Facilitation Arm 3	Experimental	Represents a higher intensity strategy using the same training program plus practice facilitation.	Other: DIGEST Training + Practice Facilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	receive no active implementation	Control Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adoption of DIGEST in routine clinical documentation for oncology MBS studies		Through study completion; an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A hospital or clinic affiliated with the Veteran's Affairs system, University of Wisconsin system, or Ohio State University system.
A minimum average of 10 Modified Barium Swallow (MBS) procedures per month in oncology patients in preceding year.
MBS imaging files are recorded and archived as a routine procedure (and accessible to researchers).

Exclusion Criteria:

N/A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kate Hutcheson, PHD	Contact	713-792-6513		karnold@mdanderson.org

Overall Officials

Name	Affiliation	Role
Kate Hutcheson, PHD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases