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

NCT04003051 | Recruiting Phase 2

• 2 other identifiers: 2018-1022NCI-2019-01687
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to 6 months post-radiation

Secondary Outcomes (1)

• Website usage data

  Up to 6 months post-radiation

Study Arms (1)

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.

Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Use Project Prepare website

Supportive Care (Project Prepare website)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (Project Prepare website)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (Project Prepare website)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Texas Health Care-Otolaryngology and Plastic Surgery Associates

Fort Worth, Texas, 76104, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Trismus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eileen H Shinn

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen H Shinn

CONTACT

713-745-0870; eshinn@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: March 18, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (2)