Malignant Neoplasms of Lip Oral Cavity and PharynxNCT03114501
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers
A study testing Yoga, Yoga Questionnaire and Symptom Questionnaires in people with Malignant Neoplasms of Lip Oral Cavity and Pharynx and Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Lip Oral Cavity and Pharynx, Head and Neck Cancer
- What is being tested?
- Yoga, Yoga Questionnaire and Symptom Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Patients) Diagnosed with a primary HNC and going to receive at least 4 weeks of RT with at least 20 fractions
- (Patients) ECOG performance status of 2 or lower
- (Patients) having an informal family caregiver (spouse, romantic partner, adult child, or sibling) who is willing to participate. If patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria.
- (Patients) having a smart phone (phase 2 only)
- (Patients and Caregivers) must be (1) at least 18 years old
- (Patients and Caregivers) able to read and speak English
- (Patients and Caregivers) able to provide informed consent
Who cannot join
- (Patients) regularly (self-defined) participated in a yoga practice in the year prior to diagnosis
- (Patients) cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
- (Patients and Caregivers) those who participate in phase 1 are ineligible to participate in phase 2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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:
- 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).
Read the detailed description
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.
- Being tested
- Yoga, Yoga Questionnaire, Symptom Questionnaires
- Keywords
- Malignant neoplasms of lip oral cavity and pharynx, Head and Neck Cancer, Yoga, Questionnaires, Surveys
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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 QuestionnaireBehavioural
Also called Survey
Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.
Symptom QuestionnairesBehavioural
Also called Surveys
Symptom questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).
| Study group | Role | What they receive |
|---|---|---|
| Yoga Program Group | Experimental | 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). Receives: Behavioral: Yoga; Behavioral: Yoga Questionnaire; Behavioral: Symptom Questionnaires |
| Waitlist Control Group (WLC) | Experimental | 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. Receives: Behavioral: Symptom Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
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.
Measured: 6 weeks after radiation therapy
Secondary outcomes (1)
Efficacy of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Efficacy of the yoga program determined by responses on quality of life (QOL) questionnaires.
Measured: 6 weeks after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start11 Apr 2017
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasms of Lip Oral Cavity and PharynxStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, MA,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114501
- Sponsor's protocol ID
- 2016-1127
- Other IDs
- NCI-2018-01163
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2017
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Milbury K, Rosenthal DI, Li Y, Ngo-Huang AT, Mallaiah S, Yousuf S, Fuller CD, Lewis C, Bruera E, Cohen L. Dyadic Yoga for Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers. J Pain Symptom Manage. 2024 Jun;67(6):490-500. doi: 10.1016/j.jpainsymman.2024.02.565. Epub 2024 Mar 5.
PubMed 38447621
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT03114501
- Acronym / sponsor ID
- 2016-1127
- Keywords
- Malignant neoplasms of lip oral cavity and pharynx, Head and Neck Cancer, Yoga, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Program Group | Experimental | Behavioral: Yoga, Behavioral: Yoga Questionnaire, Behavioral: Symptom QuestionnairesParticipants 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). |
| Waitlist Control Group (WLC) | Experimental | Behavioral: Symptom QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (Patients) Diagnosed with a primary HNC and going to receive at least 4 weeks of RT with at least 20 fractions
- (Patients) ECOG performance status of 2 or lower
- (Patients) having an informal family caregiver (spouse, romantic partner, adult child, or sibling) who is willing to participate. If patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria.
- (Patients) having a smart phone (phase 2 only)
- (Patients and Caregivers) must be (1) at least 18 years old
Key exclusion criteria (3 listed)
- (Patients) regularly (self-defined) participated in a yoga practice in the year prior to diagnosis
- (Patients) cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
- (Patients and Caregivers) those who participate in phase 1 are ineligible to participate in phase 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaParticipants 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. | Behavioural | Yoga Program Group |
| Yoga QuestionnaireAlso: SurveyQuestionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions. | Behavioural | Yoga Program Group |
| Symptom QuestionnairesAlso: SurveysSymptom questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later). | Behavioural | Waitlist Control Group (WLC), Yoga Program Group |
Primary outcome
Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Time frame: 6 weeks after radiation therapy
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.
1 secondary outcome
Efficacy of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Time frame: 6 weeks after radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Derived from this study: PubMed 38447621Milbury K, Rosenthal DI, Li Y, Ngo-Huang AT, Mallaiah S, Yousuf S, Fuller CD, Lewis C, Bruera E, Cohen L. Dyadic Yoga for Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers. J Pain Symptom Manage. 2024 Jun;67(6):490-500. doi: 10.1016/j.jpainsymman.2024.02.565. Epub 2024 Mar 5.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrin Milbury, MA,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga, Yoga Questionnaire and Symptom Questionnaires in people with Malignant Neoplasms of Lip Oral Cavity and Pharynx and Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT) (time frame: 6 weeks after radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.