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De klinische studie NCT04003051 voor Keelcarcinoom is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Kaartweergave

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

Recruterend
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De klinische studie NCT04003051 onderzoekt ondersteunende zorg bij Keelcarcinoom. Deze Fase 2 interventioneel-studie heeft de status recruterend. Het doel is om 300 deelnemers te includeren vanaf 18 maart 2019. De studie wordt geleid door MD Anderson Kankercentrum en de voltooiing is gepland op 31 december 2026. Laatste update op ClinicalTrials.gov: 3 november 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.

Officiële titel

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

Aandoeningen
Keelcarcinoom
Andere studie-ID's
NCT-ID
Startdatum (Werkelijk)
2019-03-18
Laatste update geplaatst
2025-11-03
Verwachte einddatum
2026-12-31
Inschrijving (Geschat)
300
Studietype
Interventioneel
FASE
Fase 2
Status
Recruterend
Trefwoorden
Head and neck cancer
swallowing
trismus
adherence
coping
rural
website
access
Primaire doel
Ondersteunende zorg
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelSupportive 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.
Internetgebaseerde interventie
Use Project Prepare website
Beoordeling van de kwaliteit van leven
Ancillary studies
Vragenlijstadministratie
Ancillary studies
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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.
Centraal Contactpersoon
Contact: Eileen H Shinn, 713-745-0870, [email protected]
2 Studielocaties in 1 landen

Texas

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