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

February 6, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Md Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Kate Hutcheson, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Kate Hutcheson, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1270

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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