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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (1)

• Website usage data [Срок оценки: Up to 6 months post-radiation]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Texas Health Care-Otolaryngology and Plastic Surgery Associates — Fort Worth
• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04003051 · 2018-1022 · NCI-2019-01687 · 2018-1022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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