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

NCT07283653 | Recruiting

• 1 other identifier: 2024-1270
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

DIGEST; Evidence Based Measurement; Dysphagia; Randomized Implementation

Outcome Measures

Primary Outcomes (1)

• Adoption of DIGEST in routine clinical documentation for oncology MBS studies

  Through study completion; an average of 1 year

Study Arms (3)

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

No intervention OTHER

receive no active implementation

Control Arm 1

DIGEST Training Program OTHER

Investigator led training program

Training Arm 2

DIGEST Training + Practice Facilitation OTHER

Training plus practice facilitation

Training + Practice Facilitation Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Kate Hutcheson, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Hutcheson, PHD

CONTACT

713-792-6513; karnold@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)