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

NCT ID: NCT07283653

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2029-01-31

Brief Summary

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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

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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

Conditions

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DIGEST Evidence Based Measurement Dysphagia Randomized Implementation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Arm 1

The control arm will receive no active implementation strategy.

No intervention

Intervention Type OTHER

receive no active implementation

Training Arm 2

Represents a low intensity implementation strategy solely using the DIGEST training program as the intervention.

DIGEST Training Program

Intervention Type OTHER

Investigator led training program

Training + Practice Facilitation Arm 3

Represents a higher intensity strategy using the same training program plus practice facilitation.

DIGEST Training + Practice Facilitation

Intervention Type OTHER

Training plus practice facilitation

Interventions

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No intervention

receive no active implementation

Intervention Type OTHER

DIGEST Training Program

Investigator led training program

Intervention Type OTHER

DIGEST Training + Practice Facilitation

Training plus practice facilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kate Hutcheson, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kate Hutcheson, PHD

Role: CONTACT

713-792-6513

Facility Contacts

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Kate Hutcheson, PHD

Role: primary

713-792-6513

Related Links

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http://mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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2024-1270

Identifier Type: -

Identifier Source: org_study_id

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