Hatha Yoga in Lung Cancer Couples
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01952860|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : September 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: Hatha Yoga Behavioral: Questionnaires||Not Applicable|
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 caregiving partner will be approached to take part in this study.
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, 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 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.
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 caregiving partner.
Hatha Yoga Sessions:
You will take part in up to 18 sessions of Hatha 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 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 first 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 caregiving partner or alone on the days you do not have a session at the clinic.
Length of Study:
Your participation on this study will be over when you have completed the questionnaires during your last week of radiation therapy.
This is an investigational study.
Up to 15 patients and their caregiving partners, for a total of 30 participants, will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Study of Hatha Yoga in Couples Coping With Lung Cancer|
|Actual Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Hatha Yoga
Participants receive 18 sessions of Hatha yoga over the course of radiation therapy. Each 45 to 60 minute session guided by an instructor. Participant should attend each session together with their caregiving partner. Some sessions videotaped. At first session, participant given a CD and instructions for practicing Hatha yoga at home. Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.
Other: Hatha Yoga
18 sessions of Hatha yoga over the course of radiation therapy. Each 45 to 60 minute session guided by an instructor. Participant should attend each session together with their caregiving partner. Some sessions videotaped. At first session, participant given a CD and instructions for practicing Hatha yoga at home.Behavioral: Questionnaires
Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.
Other Name: Surveys
- Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation [ Time Frame: 6 weeks ]Analysis of data focused on assessing descriptive feasibility of the yoga program. If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952860
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kathrin Milbury, PHD, MA||M.D. Anderson Cancer Center|