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RecruitingInterventionalPhase 2

Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings

NCT ID: NCT04003051Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-04-15

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.

Detailed description

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.

Arms & interventions

  • OtherInternet-Based Intervention

    Use Project Prepare website

  • OtherQuality-of-Life Assessment

    Ancillary studies

  • OtherQuestionnaire Administration

    Ancillary studies

Outcome measures

Primary

  • 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.

    Time frame: Baseline up to 6 months post-radiation

Secondary

  • Website usage data

    Time frame: Up to 6 months post-radiation

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

Texas Health Care-Otolaryngology and Plastic Surgery Associates

Fort Worth, Texas, 76104

Recruiting
Katrina M. Jensen · Contact
Eileen H. Shinn · Principal Investigator

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Eileen H. Shinn · Contact
Eileen H. Shinn · Principal Investigator