Adherence to Swallowing Exercises in Oropharyngeal Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00761397

Purpose

The purpose of this study is to compare the efficacy of a self regulation intervention with an enhanced usual care control group to increase adherence to swallowing exercises in a sample of irradiated head and neck cancer patients.

To test the mediational effects of self regulation theory in the relationship between the intervention and adherence to swallowing exercises at 12 months (mediators to be tested will be perception of illness and coping procedures).

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

MedlinePlus related topics: Cancer Exercise and Physical Fitness Head and Neck Cancer

U.S. FDA Resources

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

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

Primary Outcome Measures:

To help patients complete the swallowing exercises they are supposed to perform during radiation treatment [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	350
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 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
2 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

Men and women are eligible if they a) are on radiation treatment for oropharyngeal cancer
Are staged with T2 or higher
At least 18 years of age
Speak English
Are oriented to time, person, and place
And have a Zubrod performance status of 0 to 3.

Exclusion:

Have a tumor that is T1 in size
If they have recurrent oropharynx cancer
Have other cancer diagnoses, except non-melanoma skin cancer.
Have lymphoma

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

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

Responsible Party:	UT MD Anderson Cancer Center ( Eileen H. Shinn PHD, MS, BA/Instructor )
Study ID Numbers:	2008-0360
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761397
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

oropharyngeal cancer
dysphagic
swallowing exercises

PREPARE
Patients' Radiation Expectations
Prevention, Adherence, Rehabilitative Exercises

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms

Stomatognathic Diseases
Pharyngeal Diseases
Oropharyngeal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009