Lung CancerNCT02196844
Yoga Program for Lung Cancer Patients and Caregivers
A study testing Hatha Yoga, Questionnaires and Walk Test in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hatha Yoga, Questionnaires and Walk Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2014to 2 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with lung or esophageal cancer stages I through IIIB who are going to receive at least 5 weeks of daily thoracic radiation therapy with or without chemotherapy in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and have an eligible and consenting family caregiver living with the patient while he/she receives treatment (i.e., adult child, sibling, parent).
- Patients and caregivers must both be at least 18 years old and able to give informed consent.
- Patients and caregivers must be able to read, write, and speak English.
- Patient and caregiver must be willing to be videotaped.
Who cannot join
- Patients and caregivers who are not oriented to time, place, and person.
- Patients who have regularly practiced yoga in the year prior to recruitment.
- Patients who have an ECOG performance status score greater than 2 at time of recruitment.
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
Official title: Couple-Based Yoga Program for Patients Receiving Thoracic Radiation and Their Family Caregivers
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.
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. 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.
- Conditions
- Lung Cancer
- Being tested
- Hatha Yoga, Questionnaires, Walk Test
- Keywords
- Lung cancer, Hatha Yoga, Questionnaires, Surveys, Walk Test, Caregiver
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha YogaBehavioural
5-6 weeks of a couple-based yoga program, three sessions per week (up to 15 sessions) during radiation treatment.
QuestionnairesBehavioural
Also called Surveys
10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later.
Walk TestOther
6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Couple-Based Hatha Yoga Program: 5-6 weeks of a yoga program, three sessions per week (up to 15 sessions) during radiation treatment. At fifth session, CD given for practicing yoga at home. 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy. Receives: Behavioral: Hatha Yoga; Behavioral: Questionnaires; Other: Walk Test |
| Wait-List Control Group | Experimental | 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule, at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
Participants given the option to take part in the couple-based Hatha Yoga program (off study) after they finish their last questionnaire packet. Receives: Behavioral: Questionnaires; Other: Walk Test |
| Caregivers | Experimental | Yoga Group - Caregivers: 5-6 weeks of yoga during patient's radiation treatment. At fifth session, caregiver given CD for practicing yoga at home. During each week of patient's radiation, caregiver completes questionnaire about their feelings about yoga sessions. 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation, at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after patient's radiation therapy.
Waitlist-Control Group - Caregivers: 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation. at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after radiation therapy.
Caregivers given option to take part in yoga program after they finish their last questionnaire packet. Receives: Behavioral: Hatha Yoga; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers
Feasibility determined by 3 criteria:
- accrual of sample within 2 years; 2) adherence, retention and satisfaction rates; and 3) no serious adverse events that are directly attributable to the intervention. Trial judged feasible if at least: 50% of eligible dyads agree to randomization and enroll, 70% of enrolled dyads complete the study and at least 10 yoga sessions have been attended, and 75% of participants rate the program as "useful" or "very useful". Study conditions recruitment rate, drop-out rates, and completion rates calculated along with 95% confidence intervals (CI).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start29 Sep 2014
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, PHD, MA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196844
- Sponsor's protocol ID
- 2014-0036
- Other IDs
- 1K01AT007559-01A1, NCI-2015-01902
- Status last verified
- Feb 2023
- First submitted
- 18 Jul 2014
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple-Based Yoga Program for Patients Receiving Thoracic Radiation and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT02196844
- Acronym / sponsor ID
- 2014-0036
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Hatha Yoga, Questionnaires, Surveys, Walk Test, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 29 Sep 2014 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
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.
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. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Hatha Yoga, Behavioral: Questionnaires, Other: Walk TestCouple-Based Hatha Yoga Program: 5-6 weeks of a yoga program, three sessions per week (up to 15 sessions) during radiation treatment. At fifth session, CD given for practicing yoga at home. 10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy. |
| Wait-List Control Group | Experimental | Behavioral: Questionnaires, Other: Walk Test10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule, at radiation treatment completion, and again 3 months later. Saliva samples to measure the level of cortisol collected at baseline visit, at end of treatment, and 3 months after radiation therapy. 6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy. Participants given the option to take part in the couple-based Hatha Yoga program (off study) after they finish their last questionnaire packet. |
| Caregivers | Experimental | Behavioral: Hatha Yoga, Behavioral: QuestionnairesYoga Group - Caregivers: 5-6 weeks of yoga during patient's radiation treatment. At fifth session, caregiver given CD for practicing yoga at home. During each week of patient's radiation, caregiver completes questionnaire about their feelings about yoga sessions. 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation, at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after patient's radiation therapy. Waitlist-Control Group - Caregivers: 10 questionnaires completed before patient's first radiation treatment, each week during radiation, 5 halfway through radiation. at radiation completion, and again 3 months later. Saliva samples collected at baseline visit, at end of treatment, and 3 months after radiation therapy. Caregivers given option to take part in yoga program after they finish their last questionnaire packet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with lung or esophageal cancer stages I through IIIB who are going to receive at least 5 weeks of daily thoracic radiation therapy with or without chemotherapy in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and have an eligible and consenting family caregiver living with the patient while he/she receives treatment (i.e., adult child, sibling, parent).
- Patients and caregivers must both be at least 18 years old and able to give informed consent.
- Patients and caregivers must be able to read, write, and speak English.
- Patient and caregiver must be willing to be videotaped.
Key exclusion criteria (3 listed)
- Patients and caregivers who are not oriented to time, place, and person.
- Patients who have regularly practiced yoga in the year prior to recruitment.
- Patients who have an ECOG performance status score greater than 2 at time of recruitment.
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 |
|---|---|---|
| Hatha Yoga5-6 weeks of a couple-based yoga program, three sessions per week (up to 15 sessions) during radiation treatment. | Behavioural | Caregivers, Yoga Group |
| QuestionnairesAlso: Surveys10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later. | Behavioural | Caregivers, Wait-List Control Group, Yoga Group |
| Walk Test6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy. | Other | Wait-List Control Group, Yoga Group |
Primary outcome
Feasibility of Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers
Time frame: 6 weeks
Feasibility determined by 3 criteria: 1) accrual of sample within 2 years; 2) adherence, retention and satisfaction rates; and 3) no serious adverse events that are directly attributable to the intervention. Trial judged feasible if at least: 50% of eligible dyads agree to randomization and enroll, 70% of enrolled dyads complete the study and at least 10 yoga sessions have been attended, and 75% of participants rate the program as "useful" or "very useful". Study conditions recruitment rate, drop-out rates, and completion rates calculated along with 95% confidence intervals (CI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- 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, PHD, MA 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 Hatha Yoga, Questionnaires and Walk Test in people with Lung 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 4 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: finished, as of the sponsor's last update on 16 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Couple-Based Yoga (VKC) in Lung Cancer Patients and Caregivers (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.