NCT00761397

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
485

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

12.1 years

First QC Date

September 25, 2008

Last Update Submit

January 9, 2020

Conditions

Head and Neck Cancer

Keywords

Oropharyngeal cancerDysphagicSwallowing exercisesSwallowing rehabilitative regimensPREPAREPatients' Radiation ExpectationsPrevention, Adherence, Rehabilitative Exercises

Outcome Measures

Primary Outcomes (1)

  • Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)

    Day 1, 10 Weeks, and at 12 Months

Study Arms (2)

Study Program Group

Behavioral: InterviewBehavioral: Phone CallOther: Questionnaire

Usual Care Group

Other: BrochureOther: Questionnaire

Interventions

InterviewBEHAVIORAL

15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises

Study Program Group
Phone CallBEHAVIORAL

Phone call follow ups for 4 weeks after last radiation treatment

Study Program Group
BrochureOTHER

Detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises

Usual Care Group
QuestionnaireOTHER

Day 1 of study, 10 weeks after starting study, \& 12 months after starting study

Study Program GroupUsual Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with head and neck cancer who previously had radiation treatment

You may qualify if:

  • 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,
  • are stage II-IVB for oropharyngeal and laryngeal
  • are stage I-IVB for hypopharyngeal and nasopharyngeal
  • at least 18 years of age,
  • speak English,
  • are oriented to time, person, and place,
  • and have a Zubrod performance status of 0 to 2.

You may not qualify if:

  • have other cancer diagnoses, except non-melanoma skin cancer,
  • had treatment for previous H \& N cancer or radiation to the head and neck, or
  • history of previous head and neck surgery (excluding biopsy, tonsillectomy, tracheotomy or selective neck dissection),
  • history of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsOropharyngeal Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eileen H. Shinn, PHD, MS, BA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

August 29, 2008

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

US(1)