Clinical trial NCT01844557: Testing Accountability in Patient Adherence
Official title: Testing Accountability in Patient Adherence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head And Neck Cancer
Keywords: Head And Neck Cancer
Nasopharyngeal cancer
Oropharyngeal cancer
Hypopharyngeal cancer
Laryngeal cancer
Primary cancer with cervical metastases
Swallowing exercises
Videotape
Videocamera
M.D. Anderson Symptom Inventory
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2013-05-01
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck cancer patients receiving radiation therapy at MDACC clinics.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adherence to Swallowing Exercises
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eileen H. Shinn, PHD, MS, BA
role: PRINCIPAL_INVESTIGATOR
References: