DIGESTNCT07283653
Dissemination and Implementation of DIGEST™ as an Evidence-based Measurement Tool for Dysphagia: A Randomized Implementation Trial
A study testing DIGEST Training Program and DIGEST Training + Practice Facilitation in people with DIGEST and Evidence Based Measurement, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DIGEST, Evidence Based Measurement, Dysphagia
- What is being tested?
- DIGEST Training Program and DIGEST Training + Practice Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Kate Hutcheson, PHD, 713-792-6513, karnold@mdanderson.org
Kate Hutcheson, PHD
About this study
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.
Read the 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
- Being tested
- No intervention, DIGEST Training Program, DIGEST Training + Practice Facilitation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
receive no active implementation
DIGEST Training ProgramOther
Investigator led training program
DIGEST Training + Practice FacilitationOther
Training plus practice facilitation
| Study group | Role | What they receive |
|---|---|---|
| Control Arm 1 | Experimental | The control arm will receive no active implementation strategy. Receives: Other: No intervention |
| Training Arm 2 | Experimental | Represents a low intensity implementation strategy solely using the DIGEST training program as the intervention. Receives: Other: DIGEST Training Program |
| Training + Practice Facilitation Arm 3 | Experimental | Represents a higher intensity strategy using the same training program plus practice facilitation. Receives: Other: DIGEST Training + Practice Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of DIGEST in routine clinical documentation for oncology MBS studies
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIGESTStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Hutcheson, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283653
- Sponsor's protocol ID
- 2024-1270
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of DIGEST™ as an Evidence-based Measurement Tool for Dysphagia: A Randomized Implementation Trial
- ClinicalTrials.gov ID
- NCT07283653
- Acronym / sponsor ID
- 2024-1270
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm 1 | Experimental | Other: No interventionThe control arm will receive no active implementation strategy. |
| Training Arm 2 | Experimental | Other: DIGEST Training ProgramRepresents a low intensity implementation strategy solely using the DIGEST training program as the intervention. |
| Training + Practice Facilitation Arm 3 | Experimental | Other: DIGEST Training + Practice FacilitationRepresents a higher intensity strategy using the same training program plus practice facilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionreceive no active implementation | Other | Control Arm 1 |
| DIGEST Training ProgramInvestigator led training program | Other | Training Arm 2 |
| DIGEST Training + Practice FacilitationTraining plus practice facilitation | Other | Training + Practice Facilitation Arm 3 |
Primary outcome
Adoption of DIGEST in routine clinical documentation for oncology MBS studies
Time frame: Through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Hutcheson, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIGEST Training Program and DIGEST Training + Practice Facilitation in people with DIGEST and Evidence Based Measurement, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Hutcheson, PHD (713-792-6513, karnold@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of DIGEST in routine clinical documentation for oncology MBS studies (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.