Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies
Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Eileen H Shinn
- Phone Number: 713-745-0870
- Email: eshinn@mdanderson.org
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76104
- Recruiting
- Texas Health Care-Otolaryngology and Plastic Surgery Associates
-
Principal Investigator:
- Eileen H. Shinn
-
Contact:
- Katrina M. Jensen
- Phone Number: 817-920-0484
- Email: info@practicalslpinfo.com
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Principal Investigator:
- Eileen H. Shinn
-
Contact:
- Eileen H. Shinn
- Phone Number: 713-745-0870
- Email: eshinn@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Ancillary studies
Other Names:
Ancillary studies
Use Project Prepare website
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in self-reported swallowing function
Time Frame: Baseline up to 6 months post-radiation
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Website usage data
Time Frame: Up to 6 months post-radiation
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eileen H Shinn, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1022 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-01687 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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