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治験 NCT04003051(対象:喉頭癌)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04003051喉頭癌 に関する 支持療法 の研究で、第II相・第二段階 介入研究 臨床試験 です。現在は 募集中 で、2019年3月18日 から開始しています。300 名の参加者 の募集が計画されています。この治験は MDアンダーソンがんセンター によって主催され、2026年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月3日 です。
概要
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.
詳細説明
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.

公式タイトル

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

疾患/病気
喉頭癌
その他の研究識別子
NCT番号
開始日
2019-03-18
最終更新日
2025-11-03
終了予定日
2026-12-31
目標参加者数
300
試験の種類
介入研究
治験の相・段階
第II相・第二段階
状況
募集中
キーワード
Head and neck cancer
swallowing
trismus
adherence
coping
rural
website
access
主目的
支持療法
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
実験的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.
インターネットベースの介入
Use Project Prepare website
生活の質評価
Ancillary studies
アンケート管理
Ancillary studies
主要評価項目
評価指標指標の説明時間枠
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
副次評価項目
評価指標指標の説明時間枠
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
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • 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.
M.D. Anderson Cancer Center logoMDアンダーソンがんセンター1129 件のアクティブな治験を探索
National Cancer Institute (NCI) logoアメリカ国立がん研究所3030 件のアクティブな治験を探索
試験中央連絡先
連絡先: Eileen H Shinn, 713-745-0870, [email protected]
2 1カ国の場所

Texas

Texas Health Care-Otolaryngology and Plastic Surgery Associates, Fort Worth, Texas, 76104, United States
Katrina M. Jensen, 連絡先, 817-920-0484, [email protected]
Eileen H. Shinn, 研究責任者
募集中
M D Anderson Cancer Center, Houston, Texas, 77030, United States
Eileen H. Shinn, 連絡先, 713-745-0870, [email protected]
Eileen H. Shinn, 研究責任者
募集中