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

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Disease Information

Descriptive Information
Brief Title † Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers
Official Title † Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers
Brief Summary The goal of this behavioral research study is to learn if a partner-based yoga program can be used during treatment for cancer, and to learn the opinion of patients and their caregivers about the program. Caregivers can be informal family caregivers such as spouse, romantic partner, adult child, or sibling, and if needed, an alternate caregiver can rotate in if the first one is unavailable to attend. A caregiver or alternative caregiver must be available in order for you to take part in this study. Researchers also want to learn if and how this program affects any fatigue, sleep difficulties, depression symptoms, and overall quality of life. For comparison purposes, some participants will be assigned to take part in this program and others will not complete the program.
Detailed Description 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. You should attend each session together as partners. 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 10 questionnaires before your first radiation treatment and again after you complete your treatment schedule (usually 6 weeks later).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, 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. This is an investigational study. Up to 40 patients and their caregivers, for a total of 80 participants, will take part in this study. All will be enrolled at MD Anderson.
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Feasibility of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Secondary Outcome Measure † Efficacy of a Dyadic Yoga Program in Head and Neck Cancer (HNC) Participants Undergoing Radiotherapy (RT)
Condition † Malignant Neoplasms of Lip Oral Cavity and Pharynx Head and Neck Cancer
Intervention † BehavioralYoga
Study Arms / Comparison Groups Yoga Program Group 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). Waitlist Control Group (WLC) 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Behavioral
Estimated Enrollment † 80
Start Date † April 11, 2017
Completion Date April 2020
Primary Completion Date April 2020
Eligibility Criteria † Inclusion Criteria: 1. (Patients) Diagnosed with a primary HNC and going to receive at least 4 weeks of RT with at least 20 fractions 2. (Patients) ECOG performance status of 2 or lower 3. (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. 4. (Patients and Caregivers) must be (1) at least 18 years old 5. (Patients and Caregivers) able to read and speak English 6. (Patients and Caregivers) able to provide informed consent Exclusion Criteria: 1. (Patients) regularly (self-defined) participated in a yoga practice in the year prior to diagnosis 2. (Patients) cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Kathrin Milbury, PHD, MA, 713-745-2868, CR_Study_Registration@mdanderson.org
Location Countries † United States
Administrative Information
NCT ID † NCT03114501
Organization ID 2016-1127
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † M.D. Anderson Cancer Center
Collaborators ††
Investigators † Principal Investigator: Kathrin Milbury, PHD, MA, M.D. Anderson Cancer Center
Information Provided By
Verification Date June 2017
First Received Date † April 11, 2017
Last Updated Date June 8, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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