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Testing Accountability in Patient Adherence


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head And Neck Cancer

Thank you

Trial Information

Testing Accountability in Patient Adherence


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Adherence to Swallowing Exercises

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Eileen H. Shinn, PHD, MS, BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2013-0195

NCT ID:

NCT01844557

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

Name

Location
University of Texas MD Anderson Cancer Center Houston, Texas  77030