Recruiting
Phase 2

Project Prepare

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04003051

Conditions

Throat Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-Based Intervention

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief 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. 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.

Conditions

Throat Carcinoma

Study ID

NCT04003051

Start date

Mar 18, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Internet-Based Intervention

Use Project Prepare website

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Changes in self-reported swallowing function [ Time Frame: Baseline up to 6 months post-radiation ]

Central Contacts and Locations

Central contacts

Eileen H Shinn

713-745-0870eshinn@mdanderson.org

Locations

Texas Health Care-Otolaryngology and Plastic Surgery Associates

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Katrina M. Jensen

817-920-0484info@practicalslpinfo.com

Principal Investigator:

Eileen H. Shinn

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Eileen H. Shinn

713-745-0870eshinn@mdanderson.org

Principal Investigator:

Eileen H. Shinn

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Head and neck cancer
  • swallowing
  • trismus
  • adherence
  • coping
  • rural
  • website
  • access

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.