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Eine Studie entspricht den Filterkriterien
Kartenansicht

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

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04003051 untersucht Supportivtherapie im Zusammenhang mit Kehlkopfkarzinom. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 18. März 2019. Es ist geplant, 300 Teilnehmer aufzunehmen. Durchgeführt von MD Anderson Krebszentrum wird der Abschluss für 31. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. November 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

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

Erkrankungen
Kehlkopfkarzinom
Weitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2019-03-18
Zuletzt aktualisiert
2025-11-03
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
300
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
Head and neck cancer
swallowing
trismus
adherence
coping
rural
website
access
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellSupportive 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.
Internetbasierte Intervention
Use Project Prepare website
Lebensqualitätsbewertung
Ancillary studies
Fragebogenverwaltung
Ancillary studies
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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.
Zentrale Studienkontakte
Kontakt: Eileen H Shinn, 713-745-0870, [email protected]
2 Studienstandorte in 1 Ländern

Texas

Texas Health Care-Otolaryngology and Plastic Surgery Associates, Fort Worth, Texas, 76104, United States
Katrina M. Jensen, Kontakt, 817-920-0484, [email protected]
Eileen H. Shinn, Hauptprüfer
Offene Rekrutierung
M D Anderson Cancer Center, Houston, Texas, 77030, United States
Eileen H. Shinn, Kontakt, 713-745-0870, [email protected]
Eileen H. Shinn, Hauptprüfer
Offene Rekrutierung