Adherence to Swallowing Exercises in Oropharyngeal Cancer

This study is ongoing, but not recruiting participants.
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: September 25, 2008
Last updated: February 5, 2015
Last verified: February 2015

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 Intervention
Head and Neck Cancer
Behavioral: Interview
Behavioral: Phone Call
Other: Brochure
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Swallowing Exercises in Oropharyngeal Cancer

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: September 2008
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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.
Principal Investigator: Eileen H. Shinn, PHD, MS, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00761397     History of Changes
Other Study ID Numbers: 2008-0360
Study First Received: September 25, 2008
Last Updated: February 5, 2015
Health Authority: United States: Institutional Review Board

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
Oropharyngeal Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases processed this record on August 03, 2015