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NCT01844557 Clinical Trial

Testing Accountability in Patient Adherence

Head And Neck Cancer Clinical Trial

Official title:
Testing Accountability in Patient Adherence

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01844557
Other study ID # 2013-0195
Secondary ID 5R01DE019141-03
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2013
Est. completion date December 2021

Study information
Verified date September 2019
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving radiation treatment.

Description:

Head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. Because of these potential problems, swallowing exercises are an important part of recovery. Researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent.

If you agree to take part in this study, you will have the following procedures performed.

Videotaped Swallowing Exercise:

Researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. The length of the taping session will be 3 minutes. Afterward, you will fill out 3 questionnaires. The questionnaires will take about 10 minutes to complete.

Length of Study:

You will be asked to come in 1 time for this study.

For the next 2 years, information may be collected from your medical record. This information will include the cancer stage, if the disease has gotten worse, any treatment you receive, and any side effects you experience. This information will help researchers learn how certain treatments affect patients and their risk for future disease.

This is an investigational study.

Up to 225 patient will take part in this study. All will be enrolled at MD Anderson.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 225
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases.

2. Are stage II-IVB for oropharyngeal and laryngeal

3. Are stage I-IVB for hypopharyngeal and nasopharyngeal

4. At least 18 years of age

5. Speak and read English

6. Oriented to time, person, and place

7. Have a Zubrod performance status of 0 to 2

Exclusion Criteria:

1. Have other cancer diagnoses, except non-melanoma skin cancer

2. Had treatment for previous H & N cancer or radiation to the head and neck

3. Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)

4. Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Swallowing Exercises
Participants perform 3 swallowing exercises.
Behavioral:
• Symptom Inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
• Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence to Swallowing Exercises Purpose of experiment is to determine whether an accountability manipulation and whether human vs technological monitoring result in higher patient adherence. Main outcome measure is perseverance of effort which will be number of repetitions within one minute interval for each exercise. 1 day
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