Throat CarcinomaPhase 2NCT04003051
Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies
A Phase 2 study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Throat Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Throat Carcinoma
- What is being tested?
- Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2019to 31 Dec 2026
- Phase
- Phase 2
- 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
- Receiving radiation treatment with curative intent for throat cancer
- Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Texas Health Care-Otolaryngology and Plastic Surgery Associates
Fort Worth, Texas, 76104
Katrina M. Jensen, 817-920-0484, info@practicalslpinfo.com
Eileen H. Shinn
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Eileen H. Shinn, 713-745-0870, eshinn@mdanderson.org
Eileen H. Shinn
About this study
Official title: Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings
This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the impact of a web-based adherence program (PREPARE) on self-reported swallowing function in head and neck cancer patients during radiation.
SECONDARY OBJECTIVE:
- To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.
EXPLORATORY OBJECTIVE:
- To promote the long-term dissemination of the Dysphagia Prevention program through measurement of patient satisfaction and engagement metrics, training and continual feedback between the MD Anderson Cancer Center (MDACC) research site and community collaborative research sites.
OUTLINE:
Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.
After completion of study, patients are followed up at 6 months.
- Conditions
- Throat Carcinoma
- Being tested
- Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Head and neck cancer, swallowing, trismus, adherence, coping, rural, website, access
- Medical subject headings
- Head and Neck Neoplasms, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Use Project Prepare website
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (Project Prepare website) | Experimental | Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported swallowing function
Assessed with the MD Anderson Dysphagia Inventory (MDADI). Will first test for changes in self-reported swallowing function outcome with the MDADI between baseline and follow-up using one-tailed paired t-tests. Correlations and multivariate analyses regressing self-reported adherence to exercises against self-reported swallowing function will be analyzed similarly and appropriately.
Measured: Baseline up to 6 months post-radiation
Secondary outcomes (1)
Website usage data
Piwik analytics will be used to record usage data regarding patient engagement with the website (e.g. whether the patient looked at the website that week, number of minutes and number of navigations and pages visited).
Measured: Up to 6 months post-radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start18 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throat CarcinomaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eileen H Shinn, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003051
- Sponsor's protocol ID
- 2018-1022
- Other IDs
- NCI-2019-01687, 2018-1022
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2019
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings
- ClinicalTrials.gov ID
- NCT04003051
- Acronym / sponsor ID
- 2018-1022
- Conditions
- Throat Carcinoma
- Keywords
- Head and neck cancer, swallowing, trismus, adherence, coping, rural, website, access
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2019 (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.
This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.
Detailed description
PRIMARY OBJECTIVE:
- To determine the impact of a web-based adherence program (PREPARE) on self-reported swallowing function in head and neck cancer patients during radiation.
SECONDARY OBJECTIVE:
- To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.
EXPLORATORY OBJECTIVE:
- To promote the long-term dissemination of the Dysphagia Prevention program through measurement of patient satisfaction and engagement metrics, training and continual feedback between the MD Anderson Cancer Center (MDACC) research site and community collaborative research sites.
OUTLINE:
Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.
After completion of study, patients are followed up at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (Project Prepare website) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving radiation treatment with curative intent for throat cancer
- Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Internet-Based InterventionUse Project Prepare website | Other | Supportive Care (Project Prepare website) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (Project Prepare website) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (Project Prepare website) |
Primary outcome
Changes in self-reported swallowing function
Time frame: Baseline up to 6 months post-radiation
Assessed with the MD Anderson Dysphagia Inventory (MDADI). Will first test for changes in self-reported swallowing function outcome with the MDADI between baseline and follow-up using one-tailed paired t-tests. Correlations and multivariate analyses regressing self-reported adherence to exercises against self-reported swallowing function will be analyzed similarly and appropriately.
1 secondary outcome
Website usage data
Time frame: Up to 6 months post-radiation
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 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink 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.
Eileen H Shinn principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Throat Carcinoma, run by M.D. Anderson Cancer Center at 2 sites 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 2 inclusion and 0 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eileen H Shinn (713-745-0870, eshinn@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported swallowing function (time frame: Baseline up to 6 months post-radiation). 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 6 Oct 2026.