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临床试验 NCT04003051 针对喉癌目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies

招募中
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临床试验NCT04003051旨在研究支持治疗,主要针对喉癌。这是一项II期 (第二期) 干预性研究试验,目前试验状态为招募中。试验始于2019年3月18日,计划招募300名患者。该研究由德州大学安德森癌症中心主导,预计于2026年12月31日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年11月3日
简要概括
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.
详细描述
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.

官方标题

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

疾病
喉癌
其他研究标识符
NCT编号
实际开始日期
2019-03-18
最近更新发布
2025-11-03
预计完成日期
2026-12-31
计划入组人数
300
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
试验状态
招募中
关键词
Head and neck cancer
swallowing
trismus
adherence
coping
rural
website
access
主要目的
支持治疗
分配方式
不适用
干预模型
单组试验
盲法
无(开放性试验)
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性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.
基于互联网的干预
Use Project Prepare website
生活质量评估
Ancillary studies
问卷管理
Ancillary studies
主要终点
结果指标度量标准描述时间框架
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
次要终点
结果指标度量标准描述时间框架
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
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
  • 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.
研究中心联系人
联系人: Eileen H Shinn, 713-745-0870, [email protected]
2 位于 1 个国家/地区的研究中心

Texas

Texas Health Care-Otolaryngology and Plastic Surgery Associates, Fort Worth, Texas, 76104, United States
Katrina M. Jensen, 联系人, 817-920-0484, [email protected]
Eileen H. Shinn, 主要研究者
招募中
M D Anderson Cancer Center, Houston, Texas, 77030, United States
Eileen H. Shinn, 联系人, 713-745-0870, [email protected]
Eileen H. Shinn, 主要研究者
招募中