Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01687 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-1022 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (Project Prepare website) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Use Project Prepare website |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eileen H Shinn | Contact | 713-745-0870 | eshinn@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Eileen H Shinn | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Health Care-Otolaryngology and Plastic Surgery Associates | Recruiting | Fort Worth | Texas | 76104 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014313 | Trismus |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided