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Clinical Trials/NCT04003051
NCT04003051
Recruiting
Phase 2

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

M.D. Anderson Cancer Center3 sites in 1 country300 target enrollmentMarch 18, 2019

Overview

Phase
Phase 2
Intervention
Internet-Based Intervention
Conditions
Throat Carcinoma
Sponsor
M.D. Anderson Cancer Center
Enrollment
300
Locations
3
Primary Endpoint
Changes in self-reported swallowing function
Status
Recruiting
Last Updated
17 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
December 31, 2026
Last Updated
17 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: Internet-Based Intervention

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.

Intervention: Quality-of-Life Assessment

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.

Intervention: Questionnaire Administration

Outcomes

Primary Outcomes

Changes in self-reported swallowing function

Time Frame: Baseline up to 6 months post-radiation

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.

Secondary Outcomes

  • Website usage data(Up to 6 months post-radiation)

Study Sites (3)

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