Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02196844 |
| Other study ID # |
2014-0036 |
| Secondary ID |
1K01AT007559-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 29, 2014 |
| Est. completion date |
February 2, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this behavioral research study is to learn the opinion of patients and their
caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer.
Researchers also want to learn the effect of this program on lung function, distress,
biological function, and quality of life. For comparison purposes, there will also be a group
of participants (Group 2) that does not take part in this program.
You and your caregiver/family member will have about a 50/50 chance of being assigned to each
group. The groups are randomly assigned, but it is also based on other factors such as your
age and the status of the disease.
Description:
Caregiver:
If you agree to take part in this study, your demographic information (such as your age, sex,
and race) will be recorded. You will then be assigned to 1 of 2 study groups:
- If you are in Group 1, you will take part in the couple-based Hatha Yoga program.
- If you are in Group 2, you will not take part in the couple-based Hatha Yoga program but
will complete the same study procedures as Group 1. You will be given the option to take
part in the couple-based Hatha Yoga program (off study) after you finish your last
questionnaire packet.
You and the patient will have about a 1 in 2 chance of being assigned to each group (as in
the flip of a coin). The groups are randomly assigned, but the assignment will also depend on
the age, sex, and status of disease of the patient.
Yoga Sessions:
If you are in Group 1, you will take part in up to 15 sessions of Hatha yoga with the patient
over the course of radiation therapy (2-3 weekly sessions). Each 45- to 60-minute session
will be guided by an instructor. You should attend each session with the patient.
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 question you may
have about the practice of Hatha yoga. Most of the yoga sessions may be videotaped. This is
so the researchers can keep track of the quality of the sessions. Only the study staff will
be able to view this videotape. The video files are digital and will be deleted after all the
data are studied.
At your fifth session, you will be given a CD and instructions for practicing Hatha yoga at
home. While the patient is receiving radiation therapy, you will be asked to practice at home
1 time a day either with him/her or alone on the days you do not have a session at the
clinic. Your answers to the questions will not be shared with the patient.
During each week of radiation therapy, you will also complete a questionnaire about your
feelings about the Hatha 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 outside of class and if you think you are benefitting from
the Hatha Yoga program. It should take about 5 minutes to complete this questionnaire.
Questionnaires for All Study Participants:
You will complete about 10 questionnaires before the patient's first radiation treatment, at
the end of the treatment (usually 6 weeks later), and then again 3 months later. The
questionnaires have questions about your mood, your quality of life, your feelings about
being a caregiver, and your relationship with the patient. It should take about 45 minutes to
complete these questionnaires each time.
You will also complete about 5 questionnaires halfway through the radiation treatment
schedule. These questionnaires have questions about your quality of life. These should take
about 20 minutes to complete.
Saliva Testing for All Study Participants:
After your first visit, at the end of the patient's radiotherapy, and 3 months after the
radiation, you will be asked to provide saliva samples to measure the level of cortisol (a
stress hormone). These saliva samples will be collected 4 times a day for 2 days in a row.
You will be asked to collect the samples when you first wake up, about 45 minutes later,
about 10 hours after waking, and then at bedtime. To collect each saliva sample, you will
chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You
will write down the times at which you took these samples. You will then either bring the
samples into the clinic or mail the samples back to MD Anderson in postage-paid envelopes
that will be provided to you. The supplies needed for this testing will also be provided at
no cost to you. These saliva samples will be destroyed after being studied.
Follow-Up Phone Calls:
If you are in Group 1, after you have completed the weekly yoga classes, you will receive
phone calls from a study team member asking about your at home Hatha Yoga practice. You will
be called every other week between the end of your radiotherapy and your final visit with the
study. This will be about 5-6 phone calls and they will last approximately 10 minutes each.
Length of Study:
Your participation on this study will be over when you have completed the questionnaires at
the time of the patient's 3-month follow-up appointment in the thoracic clinic.
This is an investigational study.
Up to 50 patients and their family members, for a total of 100 participants, will take part
in this study. All will be enrolled at MD Anderson.
Patients:
If you agree to take part, your medical history and demographic information (such as your
age, sex, and race) will be recorded. By signing this consent, you also agree that your
caregiver will be approached to take part in this study.
After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 2
groups:
- Group 1 will take part in the couple-based Hatha Yoga program.
- Group 2 will not take part in the couple-based Hatha Yoga program but will complete the
same procedures as group 1. Participants in this group will be given the option to take
part in the couple-based Hatha Yoga program (off study) after they finish their last
questionnaire packet.
Group 1:
Hatha Yoga Sessions:
You and your caregiver have a 50/50 chance to be assigned to the intervention group or to the
usual care group. If you are assigned to the intervention group, you will take part in up to
15 sessions of Hatha yoga over the course of radiation therapy (2-3 weekly sessions). Each
45- to 60-minute session will be guided by an instructor. You should attend each session
together as a couple.
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 Hatha yoga. Most of the yoga sessions may be videotaped. This is
so the researchers can keep track of the quality of the sessions. Only the study staff will
be able to view this videotape. The video files are digital and will be deleted after all the
data are studied.
At your fifth session, you will be given a CD and instructions for practicing Hatha 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.
If you are assigned to the yoga group, during each week of radiation therapy, you will also
complete a questionnaire asking your feelings about the Hatha 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 outside of
class and if you think you are benefitting from the Hatha 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) and then again 3 months
later. The questionnaires ask about your health, any symptoms you may be having, your mood,
your level of fatigue, your sleeping habits, your relationship, and your quality of life. It
should take about 45 minutes to complete these questionnaires.
You will also complete about 5 questionnaires again halfway through your radiation treatment
schedule. These questionnaires ask about your quality of life. These should take about 20
minutes to complete.
Follow-Up Phone Calls:
If you are in Group 1, after you have completed the weekly yoga classes, you will receive
phone calls from a study team member asking about your at home Hatha Yoga practice. You will
be called every other week between the end of your radiotherapy and your final visit with the
study. This will be about 5-6 phone calls and they will last approximately 10 minutes each.
Saliva Testing:
After your baseline visit, at the end of treatment, and 3 months after radiotherapy, you will
be asked to provide saliva samples to measure the level of cortisol (a stress hormone). These
saliva samples will be collected 4 times a day for 2 days in a row. You will be asked to
collect the samples when you first wake up, about 45 minutes later, about 10 hours after
waking, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball
for a few seconds and then put the cotton in a small plastic tube. You will write down the
times at which you took these samples. You will then either either bring the samples into the
clinic or mail the samples back to MD Anderson in postage-paid envelopes that will be
provided to you. The tubes will also be provided at no cost to you. These saliva samples will
be sent to These saliva samples will be destroyed after being studied.
Lung Function tests:
Pulmonary Function tests (PFTs) are part of your standard treatment as a patient at MD
Anderson. We will request copies of these, as available, from your electronic medical records
at baseline and 3 months after radiotherapy.
You will also complete the 6-minute walking test. The six-minute walk test measures the
distance you are able to walk over a total of six minutes on a hard, flat surface. The goal
is to walk as far as possible in six minutes. You will be allowed to self-pace and rest as
needed during the walk along a marked walkway. You will complete a 6-minute walk at baseline,
at the end of radiotherapy, and 3 months after radiotherapy.
Length of Study:
Your participation on this study will be over when you have completed the questionnaires at
the time of your 3-month follow-up appointment in the thoracic clinic.
This is an investigational study.
Up to 50 patients and their caregivers, for a total of 100 participants, will take part in
this study. All will be enrolled at MD Anderson.
