beta
Trial Radar IA
Lo studio clinico NCT04003051 per Carcinoma della gola è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
Un studio corrisponde ai criteri del filtro
Vista a schede

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

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT04003051 è uno studio interventistico di Fase II volto a esaminare la terapia di supporto per Carcinoma della gola, attualmente in arruolamento. Avviato il 18 marzo 2019, prevede di arruolare 300 partecipanti. Sotto la guida di il Centro medico MD Anderson, dovrebbe concludersi entro il 31 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 novembre 2025.
Sommario breve
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.
Descrizione dettagliata
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.

Titolo ufficiale

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

Condizioni
Carcinoma della gola
Altri ID dello studio
Numero NCT
Data di inizio (effettiva)
2019-03-18
Ultimo aggiornamento pubblicato
2025-11-03
Data di completamento (stimata)
2026-12-31
Arruolamento (previsto)
300
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
Head and neck cancer
swallowing
trismus
adherence
coping
rural
website
access
Scopo principale
Terapia di supporto
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleSupportive 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.
Intervento basato su internet
Use Project Prepare website
Valutazione della qualità della vita
Ancillary studies
Somministrazione del questionario
Ancillary studies
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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.
National Cancer Institute (NCI) logoIstituto nazionale dei tumori, Estados Unidos3028 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Eileen H Shinn, 713-745-0870, [email protected]
2 Centri dello studio in 1 paesi

Texas

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