Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies

NCT ID: NCT04003051

Last Updated: 2025-11-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVE:

I. 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:

I. To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.

EXPLORATORY OBJECTIVE:

I. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Throat Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supportive Care (Project Prepare website)

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.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Use Project Prepare website

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Internet-Based Intervention

Use Project Prepare website

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Quality of Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eileen H Shinn

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Texas Health Care-Otolaryngology and Plastic Surgery Associates

Fort Worth, Texas, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eileen H Shinn

Role: CONTACT

713-745-0870

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Katrina M. Jensen

Role: primary

817-920-0484

Eileen H. Shinn

Role: primary

713-745-0870

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2019-01687

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-1022

Identifier Type: OTHER

Identifier Source: secondary_id

2018-1022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase II Trial Evaluating Elimination of Radiation Therapy
NCT00593840 ACTIVE_NOT_RECRUITING PHASE2
Implementation and Effectiveness Trial of HN-STAR
NCT04208490 ACTIVE_NOT_RECRUITING NA