Testing Accountability in Patient Adherence

September 9, 2019 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Anticipated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Head and neck cancer patients receiving radiation therapy at MDACC clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1(High Accountability-Human Monitoring)
Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participant to tell whether they did as many repetitions as possible and if not, why they were not able to do as many as possible. This portion of the experiment will be videotaped. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.
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.
Behavioral: Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
Other Names:
  • Surveys
Group 2(Low Accountability-Human Monitoring)
Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.
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.
Behavioral: Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
Other Names:
  • Surveys
Group 3(Low Accountability-Technological Monitoring)
Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. The videocamera will tape participant's session so evaluation can be made as to exercise accuracy. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.
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.
Behavioral: Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Swallowing Exercises
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0195
  • 5R01DE019141-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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