Testing Accountability in Patient Adherence

Trial Title: Testing Accountability in Patient Adherence

NCT ID: NCT01844557

Condition: Head And Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Conditions: Keywords:
Head And Neck Cancer
Nasopharyngeal cancer
Oropharyngeal cancer
Hypopharyngeal cancer
Laryngeal cancer
Primary cancer with cervical metastases
Swallowing exercises
Videotape
Videocamera
M.D. Anderson Symptom Inventory
Questionnaires
Surveys

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Swallowing Exercises
Description: Participants perform 3 swallowing exercises.
Arm group label: Group 1(High Accountability-Human Monitoring)
Arm group label: Group 2(Low Accountability-Human Monitoring)
Arm group label: Group 3(Low Accountability-Technological Monitoring)

Intervention type: Behavioral
Intervention name: Symptom Inventory
Description: Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Arm group label: Group 1(High Accountability-Human Monitoring)
Arm group label: Group 2(Low Accountability-Human Monitoring)
Arm group label: Group 3(Low Accountability-Technological Monitoring)

Intervention type: Behavioral
Intervention name: Questionnaires
Description: Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
Arm group label: Group 1(High Accountability-Human Monitoring)
Arm group label: Group 2(Low Accountability-Human Monitoring)
Arm group label: Group 3(Low Accountability-Technological Monitoring)

Other name: Surveys

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.

Detailed description: 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases. 2. Are stage II-IVB for oropharyngeal and laryngeal 3. Are stage I-IVB for hypopharyngeal and nasopharyngeal 4. At least 18 years of age 5. Speak and read English 6. Oriented to time, person, and place 7. Have a Zubrod performance status of 0 to 2 Exclusion Criteria: 1. Have other cancer diagnoses, except non-melanoma skin cancer 2. Had treatment for previous H & N cancer or radiation to the head and neck 3. Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy) 4. Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Start date: May 2013

Completion date: December 2021

Lead sponsor:
Agency: M.D. Anderson Cancer Center
Agency class: Other

Collaborator:
Agency: National Institute of Dental and Craniofacial Research (NIDCR)
Agency class: NIH

Source: M.D. Anderson Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01844557
http://www.mdanderson.org