Adherence to Swallowing Exercises in Head and Neck Cancer

The goal of this research study is to help patients complete the swallowing and dental care exercises they are supposed to perform during radiation treatment.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Interview; Behavioral: Phone Call; Other: Questionnaire; Other: Brochure

Detailed Description

If you agree to take part in this study, you will be taught ways to cope with the side effects of radiation as a way to help you do your swallowing exercises during radiation treatment. To find out if the swallowing exercises are being performed, researchers will compare 2 groups of participants.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups, the Study Program Group or the Usual Care Group. You will have an equal chance of being in either group.

As a part of standard of care, a speech pathologist will teach you how to perform swallowing exercises.

If you are assigned to the Study Program Group, you will complete the following:

• You will meet 1 time a week with study staff during radiation treatment either by phone or in person. These meetings will last between 15 to 30 minutes. During the meetings, you will be asked how many swallowing exercises you have completed during the last week and about any problems you may have had completing the exercises.
• You will receive phone calls for 4 weeks after the last radiation treatment. These phone calls will also last between 15 and 30 minutes. The study staff will ask questions about if you have been doing your exercises and discuss tips to help you continue to do them.
• You will receive a weekly newsletter that has information about ways to cope with any problems you may experience when completing the swallowing exercises.

If you are assigned to the Usual Care Group, you will complete the following:

• The study staff will follow up with you before and during your radiation treatments to make sure that you are scheduled with and have attended your speech pathology appointments. At these appointments, you will be taught how to do the swallowing exercises and given information to help you complete the exercises.
• You will receive a detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises.
• You will be asked if you would like to participate in another study protocol.

Questionnaires:

Participants in both groups will fill out a questionnaire asking questions about whether or not you have been completing the swallowing and dental exercises and how you have been coping with stress. The questionnaire will also collect information about the disease and demographic information such as age, gender, race, education level, and marital status. This questionnaire will take about 30 minutes to complete each time. You will complete this questionnaire on Day 1, and again 6 weeks, 6 months, 1 year, and 2 years after completing radiation treatment. The second and third questionnaires will be mailed to you along with a stamped envelope for you to return the questionnaires.

Interview:

You will be interviewed. The interview will ask questions about your successful strategies for coping with radiation side effects.

If you disclose through your assessments or discussion that you are having suicidal thoughts or could benefit from antidepressant medication, you may be referred for a consultation with Dr. Alan Valentine, an M. D. Anderson psychiatrist participating in this research study. Study staff will also let your treating doctor and/or regular doctor know about the referral for consultation.

Newsletter:

You will allow the research staff to record any successful strategies for coping with radiation side effects in a written newsletter that will be given to future participants.

Length of Study:

You will remain on study for up to 2 years.

This is an investigational study.

Up to 350 patients will take part in this study. All will be enrolled at M. D. Anderson.

• Study Type: Observational
• Enrollment (Actual): 485

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with head and neck cancer who previously had radiation treatment

Description

Inclusion Criteria:

1. Men and women are eligible if they a) are predispositioned to receive radiation treatment for oropharyngeal, laryngeal, hypopharyngeal, nasopharyngeal, 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 English,
6. are oriented to time, person, and place,
7. and 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, or
3. history of previous head and neck surgery (excluding biopsy, tonsillectomy, tracheotomy or selective neck dissection),
4. history of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Program Group	Behavioral: Interview; 15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises; Behavioral: Phone Call; Phone call follow ups for 4 weeks after last radiation treatment; Other: Questionnaire; Day 1 of study, 10 weeks after starting study, & 12 months after starting study
Usual Care Group	Other: Questionnaire; Day 1 of study, 10 weeks after starting study, & 12 months after starting study; Other: Brochure; Detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)	Day 1, 10 Weeks, and at 12 Months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); American Cancer Society, Inc.
• Investigators: Principal Investigator: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2008
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 29, 2008

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Oropharyngeal cancer; PREPARE; Dysphagic; Swallowing exercises; Swallowing rehabilitative regimens; Patients' Radiation Expectations; Prevention, Adherence, Rehabilitative Exercises
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2008-0360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No