Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03114501 |
| Other study ID # |
2016-1127 |
| Secondary ID |
NCI-2018-01163 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 11, 2017 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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).
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.
