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

Throat Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003051
• Other study ID #: 2018-1022
• Secondary ID: NCI-2019-0168720
• Status: Recruiting
• Phase: Phase 2
• Start date: March 18, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: Eileen H Shinn
• Phone: 713-745-0870
• Email: eshinn[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Throat Carcinoma

Intervention

Other:
• Internet-Based Intervention
Use Project Prepare website
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Texas Health Care-Otolaryngology and Plastic Surgery Associates	Fort Worth	Texas
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline up to 6 months post-radiation
Secondary	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).	Up to 6 months post-radiation

External Links

•   MD Anderson Cancer Center Website