Testing Accountability in Patient Adherence
9 september 2019 bijgewerkt door: M.D. Anderson Cancer Center
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. Because of these potential problems, swallowing exercises are an important part of recovery. Researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent.
If you agree to take part in this study, you will have the following procedures performed.
Videotaped Swallowing Exercise:
Researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. The length of the taping session will be 3 minutes. Afterward, you will fill out 3 questionnaires. The questionnaires will take about 10 minutes to complete.
Length of Study:
You will be asked to come in 1 time for this study.
For the next 2 years, information may be collected from your medical record. This information will include the cancer stage, if the disease has gotten worse, any treatment you receive, and any side effects you experience. This information will help researchers learn how certain treatments affect patients and their risk for future disease.
This is an investigational study.
Up to 225 patient will take part in this study. All will be enrolled at MD Anderson.
Studietype
Observationeel
Inschrijving (Verwacht)
225
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- University of Texas MD Anderson Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Head and neck cancer patients receiving radiation therapy at MDACC clinics.
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Participants perform 3 swallowing exercises.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Participants fill out 3 questionnaires after swallowing exercises.
The questionnaires will take about 10 minutes to complete.
Andere namen:
|
|
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.
|
Participants perform 3 swallowing exercises.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Participants fill out 3 questionnaires after swallowing exercises.
The questionnaires will take about 10 minutes to complete.
Andere namen:
|
|
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.
|
Participants perform 3 swallowing exercises.
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Participants fill out 3 questionnaires after swallowing exercises.
The questionnaires will take about 10 minutes to complete.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adherence to Swallowing Exercises
Tijdsspanne: 1 day
|
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.
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1 day
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 mei 2013
Primaire voltooiing (Verwacht)
1 december 2020
Studie voltooiing (Verwacht)
1 december 2021
Studieregistratiedata
Eerst ingediend
29 april 2013
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2013
Eerst geplaatst (Schatting)
1 mei 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 september 2019
Laatste update ingediend die voldeed aan QC-criteria
9 september 2019
Laatst geverifieerd
1 september 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2013-0195
- 5R01DE019141-03 (Subsidie/contract van de Amerikaanse NIH)
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