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Adherence to Swallowing Exercises in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00761397
Recruitment Status : Active, not recruiting
First Posted : September 29, 2008
Last Update Posted : June 19, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Head and Neck Cancer Behavioral: Interview Behavioral: Phone Call Other: Brochure Other: Questionnaire

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Study Design

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Swallowing Exercises in Head and Neck Cancer
Actual Study Start Date : September 2008
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with head and neck cancer who previously had radiation treatment

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761397

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Eileen H. Shinn, PHD, MS, BA M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00761397     History of Changes
Other Study ID Numbers: 2008-0360
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017

Keywords provided by M.D. Anderson Cancer Center:
Oropharyngeal cancer
Swallowing exercises
Swallowing rehabilitative regimens
Patients' Radiation Expectations
Prevention, Adherence, Rehabilitative Exercises

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site