Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments swallowing exercises, symptom inventory, questionnaires
Phase phase 1/phase 2
Sponsor M.D. Anderson Cancer Center
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date May 2013
End date May 2018
Trial size 225 participants
Trial identifier NCT01844557, 2013-0195, 5R01DE019141-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
swallowing exercises
Participants perform 3 swallowing exercises.
symptom inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
questionnaires Surveys
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
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.
swallowing exercises
Participants perform 3 swallowing exercises.
symptom inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
questionnaires Surveys
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
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.
swallowing exercises
Participants perform 3 swallowing exercises.
symptom inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
questionnaires Surveys
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.

Primary Outcomes

Measure
Adherence to Swallowing Exercises
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Testing Accountability in Patient Adherence
Principal investigator Eileen H. Shinn, PHD, MS, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.