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Adherence to Swallowing Exercises in Oropharyngeal Cancer

This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00761397
First received: September 25, 2008
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 2014 (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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761397

Contacts
Contact: Eileen H. Shinn, PHD, MS, BA 713-792-0919
Contact: Jan S. Lewin, PHD, MS, BA 713-745-2309

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen Basen-Engquist, PHD, BA, MPH            
Principal Investigator: Eileen H. Shinn, PHD, MS, BA            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eileen H. Shinn, PHD, MS, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00761397     History of Changes
Other Study ID Numbers: 2008-0360
Study First Received: September 25, 2008
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013