Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Head and Neck Neoplasms

Lip Neoplasms

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Participants take part in the partner-based yoga program.

Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.

Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Participants receive standard of care.

Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

After the study has been completed, participant and caregiver/alternative caregiver offered the opportunity to take part in the partner-based yoga program.

Participants receive yoga sessions up to 5 days per week, based on the patient's schedule, over the course of patients' Radiation Therapy (up to 15 sessions, 45-60 min. each). Yoga sessions audio and video recorded.

Yoga

Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.

Yoga Questionnaire

Symptom questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Symptom Questionnaires

Kathrin Milbury, MA,PHD

Objectives:

Primary Aim:

Examine the feasibility of a dyadic yoga program in 40 Head and Neck Cancer (HNC) patients undergoing radiotherapy (RT) and their family caregivers.

Secondary Aims:

1. Establish the initial efficacy of the yoga program in patients and their caregivers regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL) and objective performance outcomes (i.e, sit to stand test and grip strength).

Caregiver:

If you agree to take part in this study, your demographic information (such as your age, sex, and race) will be recorded at your first visit.

After your first visit, you and the patient will be assigned to 1 of 2 groups. You will either automatically be assigned to Group 1 if you are in the first 10 couples to join the study, or you will be randomly assigned (as in the roll of dice) to Group 1 or Group 2.

This random assignment is done because no one knows if one study group is better, the same, or worse than the other group. You have about an equal chance of being assigned to each group. However, the assignment is also based on other factors such as age and disease status.

If you are in Group 1, you will take part in the partner-based yoga program.

If you are in Group 2, you will not take part in the partner-based yoga program but will complete the same questionnaires as Group 1. After the study has been completed, you and the patient will be offered the opportunity to take part in the partner-based yoga program. This will be offered outside the study and will be offered at no cost to you.

Group 1 - Yoga Sessions and Alternate Caregiver Questionnaire:

If you are in Group 1, you will take part in up to 15 sessions of yoga over the course of the patient's radiation therapy. Each 45- to 60-minute session will be guided by an instructor either face-to-face or by videoconferencing (FaceTime). You should attend each session together as partners.

If you do not have access to a personal handheld device (such as an iPhone or iPad), an iPad will be assigned to you. You will be asked to complete an iPad agreement form and return the iPad on the date that is noted in the agreement. If the device breaks, please tell the study staff right away.

During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of yoga.

The yoga sessions may be audio- and video-recorded. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to review this tape. The audio and video files are digital and will be destroyed after 7 years. If you do not allow the sessions to be audio- or video-recorded, you cannot take part in this study.

At your fifth session, you will be given a DVD and instructions for practicing yoga at home. While the patient is receiving radiation therapy, you will be asked to practice at home 1 time a day either with the patient or alone on the days you do not have a session at the clinic.

During each week of radiation therapy, you will also complete a questionnaire on your feelings about the yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice yoga outside of class and if you think you are benefitting from the yoga program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with the patient.

If you are an alternate caregiver, you will complete a quality-of-life questionnaire at your first yoga session and at the end of the patient's treatment. The questionnaire at the end of treatment can be completed by mail, over the phone with the study staff, or at a clinic session. Completing the questionnaire should take less than 10 minutes.

Groups 1 and 2 - Questionnaires:

You will complete about 12 questionnaires before the patient's first radiation treatment) and again 3 months later. The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, health care, work productivity, and quality of life. It should take about 55 minutes to complete these questionnaires.

During the last week of the patient's radiation therapy, you will complete about 8 questionnaires. The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, and quality of life. It should take about 45 minutes to complete these questionnaires.

Length of Study:

Your participation on this study will be over when you have completed the last questionnaires.

Patient:

If you agree to take part in this study, your medical history and demographic information (such as your age, sex, and race) will be recorded at your first visit. Additional medical information will be collected from your medical record, such as current/past nicotine use.

If you sign this consent, your caregiver will be approached to take part in this study.

After your first visit, you and your caregiver will be assigned to 1 of 2 groups. You will either automatically be assigned to Group 1 if you are in the first 10 couples to join the study, or you will be randomly assigned (as in the roll of dice) to Group 1 or Group 2.

This random assignment is done because no one knows if one study group is better, the same, or worse than the other group. You have about an equal chance of being assigned to each group. However, the assignment is also based on other factors such as your age and the status of the disease.

If you are in Group 1, you will take part in the partner-based yoga program.

If you are in Group 2, you will not take part in the partner-based yoga program but will complete the same questionnaires as Group 1. After the study has been completed, you and your caregiver/alternative caregiver will be offered the opportunity to take part in the partner-based yoga program.

Group 1 - Yoga Sessions:

If you are in Group 1, you will take part in up to 15 sessions of yoga over the course of radiation therapy. Each 45- to 60-minute session will be guided by an instructor either face-to-face or by videoconferencing (FaceTime). You should attend each session together as partners.

If you do not have access to a personal handheld device (such as an iPhone or iPad), an iPad will be assigned to you. You will be asked to complete an iPad agreement form and return the iPad on the date that is noted in the agreement. If the device breaks, please tell the study staff right away.

During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of yoga.

The yoga sessions may be audio- and video recorded. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to review this tape. The audio and video files are digital and will be destroyed after 7 years. If you do not allow the sessions to be audio- or video-recorded, you cannot take part in this study.

At your fifth session, you will be given a DVD and instructions for practicing yoga at home. While you are receiving radiation therapy, you will be asked to practice at home 1 time a day either with your caregiver or alone on the days you do not have a session at the clinic.

During each week of radiation therapy, you will also complete a questionnaire on your feelings about the yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice yoga outside of class and if you think you are benefitting from the yoga program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with your caregiver.

Groups 1 and 2 - Questionnaires:

You will complete about 12 questionnaires before your first radiation treatment and again 3 months later The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, health care, work productivity, and quality of life. It should take about 55 minutes to complete these questionnaires.

During your last week of radiation therapy, you will complete about 8 questionnaires. The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, and quality of life. It should take about 45 minutes to complete these questionnaires.

During Week 3 of radiation therapy and 4 weeks after radiation therapy, you will complete the symptom questionnaire. It should take about 5 minutes to complete. You can complete it over the phone with the study staff or at a clinic session.

Additional Tests for Both Groups:

You will complete a sit-to-stand and grip strength test before your first radiation treatment and once weekly at radiation therapy visits during the time that you receive radiation therapy. The sit-to-stand test measures how easily you sit down and stand up out of a chair. The grip strength test measures the strength of your hands and lower arms. These tests should take about 5 minutes to complete.

Length of Study:

Your participation on this study will be over when you have completed the last questionnaires.

Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers

Trial considered feasible if 1) ≥ 50% of eligible couples consent (i.e., approach 80 couples to obtain 40 consents); 2) ≥ 70% of enrolled couples complete both assessments; 3) on average ≥ 50% of all practice sessions are attended.

Efficacy of the yoga program determined by responses on quality of life (QOL) questionnaires.

M.D. Anderson Cancer Center

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

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.

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.

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.

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.

Dysphagia Inventory Questionnaire

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Activity Bands

Neil Gross, MD

MD Anderson Health Information Specialist

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:

* Participant will complete questionnaires about any symptoms of cancer they may be having and how they affect their daily life at work and at home, their diet, and their speech.
* Participant will complete the Dysphagia Inventory. This is a questionnaire about how difficult it is to swallow.
* The study staff will measure how wide participant can open their jaw to see if their treatment may cause any jaw opening limitations.

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:

* Participant's medical history
* The results of participant's physical exam including their weight and any recent weight loss.
* Any other diseases participant may have and any drugs they are currently taking.
* Participant's current smoking status and smoking history.

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.

* The data from participant's wristband will be collected.
* Participant will complete the same questionnaires they did at baseline.
* At participant's 3 month visit only, the study staff will measure how wide they can open their jaw to see if their treatment may cause any jaw opening limitations.

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.

Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell

Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma

Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.

Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers	NCT03114501	Malignant Neopl... Head and Neck C...	Yoga Yoga Questionna... Symptom Questio...	18 Years -	M.D. Anderson Cancer Center
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers	NCT03114501	Malignant Neopl... Head and Neck C...	Yoga Yoga Questionna... Symptom Questio...	18 Years -	M.D. Anderson Cancer Center
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell	NCT02663583	Cancer of the M... Oropharynx Squa...	Symptom Questio... Dysphagia Inven... Activity Bands	18 Years -	M.D. Anderson Cancer Center
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell	NCT02663583	Cancer of the M... Oropharynx Squa...	Symptom Questio... Dysphagia Inven... Activity Bands	18 Years -	M.D. Anderson Cancer Center
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers	NCT03114501	Malignant Neopl... Head and Neck C...	Yoga Yoga Questionna... Symptom Questio...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for symptom questionnaires