Adherence to Swallowing Exercises in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Adherence to Swallowing Exercises in Head and Neck Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00761397
• Other study ID #: 2008-0360
• Status: Active, not recruiting
• Start date: August 29, 2008
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 485
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• Interview
15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises
• Phone Call
Phone call follow ups for 4 weeks after last radiation treatment

Other:
• Brochure
Detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises
• Questionnaire
Day 1 of study, 10 weeks after starting study, & 12 months after starting study

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	American Cancer Society, Inc., National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)		Day 1, 10 Weeks, and at 12 Months

External Links

•   University of Texas MD Anderson Cancer Center Website