Testing Accountability in Patient Adherence
9 settembre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Anticipato)
225
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Texas
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Houston, Texas, Stati Uniti, 77030
- University of Texas MD Anderson Cancer Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Head and neck cancer patients receiving radiation therapy at MDACC clinics.
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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.
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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.
Altri nomi:
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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.
Altri nomi:
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Adherence to Swallowing Exercises
Lasso di tempo: 1 day
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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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 maggio 2013
Completamento primario (Anticipato)
1 dicembre 2020
Completamento dello studio (Anticipato)
1 dicembre 2021
Date di iscrizione allo studio
Primo inviato
29 aprile 2013
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2013
Primo Inserito (Stima)
1 maggio 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 settembre 2019
Ultimo verificato
1 settembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2013-0195
- 5R01DE019141-03 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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