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Internet-Based Intervention for Head and Neck Cancer
Phase 2
Recruiting
Led By Eileen H Shinn
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-radiation
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether a web program can help patients with head and neck cancer stick to their swallowing exercises and coping strategies.
Who is the study for?
This trial is for patients with head and neck cancer, specifically those undergoing radiation therapy aimed at curing throat cancer. Participants must be able to read and speak English or Spanish well enough to use the web-based program and respond to questionnaires.
What is being tested?
The study is testing 'Project Prepare,' a web-based program designed to help patients stick to swallowing exercises and learn coping strategies. The goal is to see if this tool can improve adherence and reduce long-term side effects from radiation therapy.
What are the potential side effects?
Since the intervention involves non-invasive support through a website, there are no direct medical side effects associated with it. However, participants may experience frustration or fatigue from regular exercise practice.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months post-radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post-radiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in self-reported swallowing function
Secondary study objectives
Website usage data
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (Project Prepare website)Experimental Treatment3 Interventions
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.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,026 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,793 Total Patients Enrolled
1 Trials studying Throat Cancer
20 Patients Enrolled for Throat Cancer
Eileen H ShinnPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
471 Total Patients Enrolled