An observational study in Cancer of the Mouth and Oropharynx Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by M.D. Anderson Cancer Center · Observational
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.
Baseline Visit:
If participant agrees to take part in this study, they will complete the following tests and procedures at their baseline visit. This baseline visit will take place before participant's treatment with IMPT or TORS:
It should take about 30 minutes to complete all of the questionnaires.
As part of participant's baseline visit, information below will be collected from their medical record:
Activity Bands:
The study staff will either give participant an activity band at their baseline visit or they will be mailed an activity wristband. Participant will be asked to wear the band 24 hours a day for 1 week leading up to all study visits. The wristband will record how active participant is and how much they sleep. The study staff will show participant how to wear and use the wristband.
Study Visits:
Participant will complete the following study procedures after they complete treatment with either IMPT or TORS, and at 3 and 6 months after that.
IMPT patients only:
If participant is receiving IMPT, they will complete the questionnaires they completed at the baseline visit once a week while they are receiving treatment.
Length of Study:
Participant's active participation in this study will be over after the 6 month study visit.
Participant will return the wristband to the study staff after their participation is over. If participant loses or damages the wristband while they are on study, another one will be provided to them at no cost.
This is an investigational study.
Up to 44 participants will take part in this study. All will be enrolled at MD Anderson.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's planned enrollment of 44 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 579 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants having treatment with either proton therapy (called Intensity-Modulated Proton Therapy or IMPT) or robotic surgery (called TransOral Robotic Surgery or TORS) at MD Anderson Cancer Center in Houston, Texas.
Exclusion Criteria:
N/A
Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
Behavioral: Symptom Questionnaires · Behavioral: Dysphagia Inventory Questionnaire · Behavioral: Activity Bands
Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
Behavioral: Symptom Questionnaires · Behavioral: Dysphagia Inventory Questionnaire · Behavioral: Activity Bands
Intensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.
Also known as: Surveys
Intensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.
Also known as: Survey
Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.
Time frame: 6 months
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).
Time frame: 6 Months
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center