NCT01844557

Brief Summary

The goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving 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
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

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

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

7.6 years

First QC Date

April 29, 2013

Last Update Submit

September 9, 2019

Conditions

Head And Neck Cancer

Keywords

Head And Neck CancerNasopharyngeal cancerOropharyngeal cancerHypopharyngeal cancerLaryngeal cancerPrimary cancer with cervical metastasesSwallowing exercisesVideotapeVideocameraM.D. Anderson Symptom InventoryQuestionnairesSurveys

Outcome Measures

Primary Outcomes (1)

  • Adherence to Swallowing Exercises

    Purpose of experiment is to determine whether an accountability manipulation and whether human vs technological monitoring result in higher patient adherence. Main outcome measure is perseverance of effort which will be number of repetitions within one minute interval for each exercise.

    1 day

Study Arms (3)

Group 1(High Accountability-Human Monitoring)

Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participant to tell whether they did as many repetitions as possible and if not, why they were not able to do as many as possible. This portion of the experiment will be videotaped. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.

Other: Swallowing ExercisesBehavioral: Symptom InventoryBehavioral: Questionnaires

Group 2(Low Accountability-Human Monitoring)

Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.

Other: Swallowing ExercisesBehavioral: Symptom InventoryBehavioral: Questionnaires

Group 3(Low Accountability-Technological Monitoring)

Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. The videocamera will tape participant's session so evaluation can be made as to exercise accuracy. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire.

Other: Swallowing ExercisesBehavioral: Symptom InventoryBehavioral: Questionnaires

Interventions

Swallowing ExercisesOTHER

Participants perform 3 swallowing exercises.

Group 1(High Accountability-Human Monitoring)Group 2(Low Accountability-Human Monitoring)Group 3(Low Accountability-Technological Monitoring)
Symptom InventoryBEHAVIORAL

Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.

Group 1(High Accountability-Human Monitoring)Group 2(Low Accountability-Human Monitoring)Group 3(Low Accountability-Technological Monitoring)
QuestionnairesBEHAVIORAL

Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.

Also known as: Surveys
Group 1(High Accountability-Human Monitoring)Group 2(Low Accountability-Human Monitoring)Group 3(Low Accountability-Technological Monitoring)

Eligibility Criteria

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

Head and neck cancer patients receiving radiation therapy at MDACC clinics.

You may qualify if:

  • Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, 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 and read English
  • Oriented to time, person, and place
  • 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
  • Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
  • Have a 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 NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsHypopharyngeal NeoplasmsLaryngeal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

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

April 29, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

US(1)